K960001 |
01/02/1996 |
MINIMED INFUSION PUMP, MODEL MMT-507 |
MEDTRONIC MINIMED |
K221356 |
05/10/2022 |
Wee Bell |
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K970570 |
02/14/1997 |
NIVP3 (WINDOWS VERSION OF NIVP |
D. E. HOKANSON, INC. |
K041689 |
06/22/2004 |
POLYURETHANE BLOOD PRESSURE CUFFS |
D. E. HOKANSON, INC. |
K982707 |
08/03/1998 |
EC6 PLETHYSMOGRAPH |
D. E. HOKANSON, INC. |
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K033156 |
09/30/2003 |
OB1 OBSTETRICAL DOPPLER |
D. E. HOKANSON, INC. |
K023707 |
11/04/2002 |
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D. E. HOKANSON, INC. |
K180247 |
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DAEHAN Adhesive Surface Electrodes |
Daehan Medical Systems Co., Ltd. |
K212516 |
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IRNF App |
Apple Inc. |
K161530 |
06/02/2016 |
Bluetooth blood pressure monitor |
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. |
K062033 |
07/18/2006 |
BP 101 DIGITAL BLOOD PRESSURE MONITOR |
KING YIELD HONGKONG LIMITED |
K112042 |
07/18/2011 |
KINGYIELD WRIST BLOOD PRESSURE MONITOR |
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. |
K182018 |
07/27/2018 |
Bluetooth blood pressure monitor |
Shenzhen Kingyield Technology Co., Ltd. |
K083043 |
10/14/2008 |
KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201 |
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. |
K211016 |
04/05/2021 |
Powered Breast Pump (Models 7V and 7X) |
Haenim Co., Ltd. |
K220990 |
04/04/2022 |
Qorda QD1 |
Winix Inc. |
K063545 |
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MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE |
ALFA SCIENTIFIC DESIGNS, INC. |
K992619 |
08/04/1999 |
AMIGO MODEL 680000 (AMIGO EXCITE F 350) |
AMIGO MOBILITY INTL., INC. |
K983987 |
11/09/1998 |
AMIGO MODEL 590000 |
AMIGO MOBILITY INTL., INC. |
K120047 |
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CORAL SPINAL SYSTEM |
THEKEN SPINE, LLC |
K070381 |
02/08/2007 |
THEKEN VU MESH VBR SYSTEM |
THEKEN SPINE LLC |
K070638 |
03/07/2007 |
THEKEN ATOLL CERVICO-THORACIC SYSTEM |
THEKEN SPINE LLC |
K080690 |
03/11/2008 |
MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM |
THEKEN SPINE LLC |
K120829 |
03/19/2012 |
STAINLESS STEEL SPINAL SYSTEM |
THEKEN SPINE, LLC |
K080790 |
03/20/2008 |
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM |
THEKEN SPINE LLC |
K070786 |
03/22/2007 |
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT |
THEKEN SPINE LLC |
K080822 |
03/24/2008 |
VU APOD INTERVERTABRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
K070962 |
04/05/2007 |
CORAL PEDICLE SCREW SYSTEM |
THEKEN SPINE LLC |
K100970 |
04/08/2010 |
STAINLESS STEEL SPINAL SYSTEM |
THEKEN SPINE LLC |
K071031 |
04/11/2007 |
VU E*POD VERTEBRAL BODY REPLACEMENT |
THEKEN SPINE LLC |
K121211 |
04/20/2012 |
VU APOD INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE, LLC |
K161184 |
04/27/2016 |
iNSitu Total Hip System |
Theken Companies, LLC |
K091266 |
04/30/2009 |
THEKEN CORAL SPINAL SYSTEM |
THEKEN SPINE LLC |
K181287 |
05/16/2018 |
Catalyst CSR Shoulder System |
Catalyst OrthoScience, Inc. |
K121482 |
05/18/2012 |
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY |
THEKEN SPINE LLC |
K081414 |
05/20/2008 |
MODIFICATION TO CORAL SPINAL SYSTEM |
THEKEN SPINE LLC |
K111675 |
06/15/2011 |
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
K211991 |
06/28/2021 |
Catalyst R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
K191811 |
07/05/2019 |
Catalyst OrthoScience CSR Shoulder System |
Catalyst OrthoScience, Inc. |
K222317 |
08/02/2022 |
Catalyst EA Convertible Stemmed Shoulder |
Catalyst OrthoScience, Inc. |
K102323 |
08/17/2010 |
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
K172501 |
08/18/2017 |
iNSitu Total Hip System |
Theken Companies, LLC |
K232583 |
08/25/2023 |
Catalyst R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
K072407 |
08/27/2007 |
BODYFORM THORACIC FIXATION SYSTEM |
THEKEN SPINE LLC |
K202611 |
09/09/2020 |
Catalyst OrthoScience R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
K182500 |
09/12/2018 |
Catalyst CSR Press-Fit Humeral Components |
Catalyst OrthoScience, Inc. |
K082712 |
09/16/2008 |
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM |
THEKEN SPINE LLC |
K112986 |
10/06/2011 |
LATERAL FUSION DEVICE |
INTEGRA SPINE (INTEGRA LIFESCIENCES) |
K213349 |
10/08/2021 |
Catalyst R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc |
K083073 |
10/15/2008 |
THEKEN ATOLL CERVICO-THORACIC SYSTEM |
THEKEN SPINE LLC |
K103228 |
11/02/2010 |
PARAMOUNT R IBF DEVICE |
THEKEN SPINE LLC |
K223655 |
12/06/2022 |
Catalyst R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
K173812 |
12/15/2017 |
Catalyst CSR 3 Peg Glenoids |
Catalyst OrthoScience, Inc |
K083863 |
12/29/2008 |
THEKEN ATOLL OCT SPINAL SYSTEM |
THEKEN SPINE LLC |
DEN980003 |
05/18/1998 |
DIAMOND PROBE/PERIO 2000 SYSTEM |
DIAMOND GENERAL DEVELOPMENT CORP. |
K150272 |
02/04/2015 |
Capnostream 35 Portable Respiratory Monitor |
ORIDION MEDICAL 1987 LTD. |
K181467 |
06/04/2018 |
Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line |
Oridion Medical 1987 Ltd. |
K181624 |
06/20/2018 |
Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line |
Oridion Medical 1987 Ltd. |
K121927 |
07/02/2012 |
MICROSTREAM FILTERLINE ICU |
ORIDION MEDICAL 1987 LTD. |
K032362 |
07/31/2003 |
UP-GRADE FOREHEAD THERMOMETER |
MEDISIM LTD. |
K123690 |
12/03/2012 |
CAPNOSTREAM20P WITH HIFI C02 MONITORING |
ORIDION MEDICAL 1987 LTD. |
K173919 |
12/22/2017 |
HX Device |
Human Extension Ltd. |
K103040 |
10/13/2010 |
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
LANX, LLC |
K103237 |
11/02/2010 |
LANX SPINAL SYSTEM |
LANX, INC. |
K080217 |
01/29/2008 |
COMPONENT NEUROMONITORING SYSTEM |
MOBERG RESEARCH, INC. |
K141165 |
05/06/2014 |
MATRIXWAVE MMF SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
K133616 |
11/25/2013 |
MATRIXRIB FIXATION SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
K212751 |
08/30/2021 |
Powder Free Nitrile Examination Glove |
Dainam Glove Joint Stock Company |
K070676 |
03/12/2007 |
KOREBALANCE (KINESTHETIC ABILITY TRAINER) |
SPORTKAT, LLC |
K954922 |
10/26/1995 |
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS |
REXTON, INC. |
K122050 |
07/12/2012 |
CPRMETER CPR FEEDBACK DEVICE |
LAERDAL MEDICAL A/S |
K141410 |
05/29/2014 |
ORAGENE DX OGD-500.001 |
DNA GENOTEK, INC. |
K152464 |
08/31/2015 |
ORAcollect.Dx |
DNA GENOTEK INC. |
K152556 |
09/08/2015 |
Oragene Dx |
DNA Genotek Inc |
K200098 |
01/16/2020 |
VagiVital Aktivgel |
Peptonic Medical AB |
K121254 |
04/25/2012 |
CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE |
CAMBER SPINE TECHNOLOGIES |
K142494 |
09/05/2014 |
ViMove |
dorsaVi Ltd. |
K163150 |
11/09/2016 |
ViMove2 |
DORSAVI LTD |
K083399 |
11/17/2008 |
ICS CHARTR EP 200 |
GN OTOMETRICS A/S |
K060860 |
03/29/2006 |
TURKOM-CERA |
DENTAL SUPPLIERS OF AMERICA, INC. |
K001213 |
04/14/2000 |
CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 |
HUDSON RESPIRATORY CARE, INC. |
K140141 |
01/22/2014 |
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM |
CERAGEM MEDISYS INC. |
K140813 |
04/01/2014 |
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES |
COVIDIEN |
K131614 |
06/03/2013 |
REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM |
COVIDIEN |
K111887 |
07/01/2011 |
CLOSUREFAST RADIOFREQUENCY CATHETER |
COVIDIEN |
K071920 |
07/12/2007 |
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
K092205 |
07/22/2009 |
PALINDROME P HEMODIALYSIS CATHETER |
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
K062326 |
08/09/2006 |
AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
K102605 |
09/10/2010 |
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER |
COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA |
K092797 |
09/11/2009 |
ACUTE AND CHRONIC CATHETER REPAIR KIT |
KENDALL |
K120714 |
03/08/2012 |
PICASSO MIS SPINAL FIXATION SYSTEM |
ACCEL SPINE |
K121078 |
04/09/2012 |
VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM |
ACCEL SPINE |
K121136 |
04/13/2012 |
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM |
ACCEL SPINE |
K121567 |
05/29/2012 |
ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM |
ACCEL SPINE |
K121568 |
05/29/2012 |
DALI SPINAL FIXATION SYSTEM |
ACCEL SPINE |
K121569 |
05/29/2012 |
MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM |
ACCEL SPINE |
K092488 |
08/13/2009 |
DYNAREX STERILE LUBRICATING JELLY |
DYNAREX CORPORATION |
K102637 |
09/14/2010 |
DYNAREX ULTRASOUND GEL |
DYNAREX CORPORATION |
K103086 |
10/19/2010 |
DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC |
DYNAREX CORPORATION |
K982508 |
07/20/1998 |
FLEXIMA |
BOSTON SCIENTIFIC CORP. |
K140101 |
01/15/2014 |
ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS |
ABMEDICA SAS |
K121336 |
05/03/2012 |
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 |
SURGIQUEST, INC. |
K132169 |
07/15/2013 |
SURGIQUEST AIRSEAL IFS |
SURGIQUEST, INC. |
K143404 |
11/28/2014 |
SurgiQuest AirSeal iFS System |
SURGIQUEST, INC. |
K103692 |
12/17/2010 |
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 |
SURGIQUEST, INC. |
K990863 |
03/16/1999 |
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
K031407 |
05/05/2003 |
ROSS EMBRACE ENTERAL PUMP |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
K011467 |
05/14/2001 |
ROSS EMBRACE PUMP SET |
ROSS PRODUCTS |
K972437 |
06/30/1997 |
ROSS ENTERAL FEEDING TUBE |
ROSS PRODUCTS |
K962554 |
07/01/1996 |
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE |
ABBOTT LABORATORIES |
K992494 |
07/26/1999 |
FLEXIFLO ENTERAL FEEDING TUBE |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
K963113 |
08/12/1996 |
FLEXIFLO POLYG GASTOSTOMY TUBE |
ABBOTT LABORATORIES |
K162723 |
09/29/2016 |
TransFix/EDTA Vacuum Blood Collection Tubes |
Caltag Medsystems Ltd. |
K010703 |
03/09/2001 |
INTER-VIAL |
DUOJECT MEDICAL SYSTEMS, INC. |
K172064 |
07/07/2017 |
Ti-Diagon Oblique TLIF |
Camber Spine Technologies |
K193153 |
11/13/2019 |
SPIRA-C Integrated Fixation System |
Camber Spine Technologies |
K153156 |
11/02/2015 |
eCareManager 4.0.1 |
VISICU, INC. |
K081234 |
05/01/2008 |
GN OTOMETRICS INSERT EARPHONES |
GN OTOMETRICS |
K112621 |
09/08/2011 |
WIS1000 |
FORESEESON CUSTOM DISPLAYS, INC. |
K955770 |
12/21/1995 |
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM |
ABAXIS, INC. |
K210609 |
03/01/2021 |
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens |
VP Optics |
K133366 |
11/01/2013 |
ORTHROS POSTERIOR STABILIZATION SYSTEM |
CAMBER SPINE |
K133529 |
11/15/2013 |
CAMBER SPINE COVERIS CERVICAL CAGE |
CAMBER SPINE |
K134038 |
12/31/2013 |
CAMBER SPINE DIAGON OBLIQUE CAGE |
CAMBER SPINE |
K203503 |
11/30/2020 |
Camber Sacroiliac (SI) Fixation System |
Camber Spine Technologies, LLC |
K143490 |
12/08/2014 |
VERTA Corpectomy Cage |
CAMBER SPINE |
K072032 |
07/24/2007 |
IGG ANTI-ATHEROX TEST KIT |
CORGENIX, INC. |
K960295 |
01/22/1996 |
LONG LIFE RX-12 |
REXTON, INC. |
K964451 |
11/06/1996 |
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC |
REXTON, INC. |
K974788 |
12/22/1997 |
CRE(TM) BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
K040244 |
02/03/2004 |
MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6 |
THE MICROOPTICAL CORPORATION |
K070405 |
02/12/2007 |
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT |
COOK BIOTECH, INC. |
K991056 |
03/30/1999 |
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORP. |
K961349 |
04/08/1996 |
INJECTION GOLD PROBE |
BOSTON SCIENTIFIC CORP. |
K961438 |
04/15/1996 |
BALLON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
K051134 |
05/03/2005 |
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A |
PHILIPS MEDICAL SYSTEMS |
K952262 |
05/15/1995 |
SPEEDBAND |
BOSTON SCIENTIFIC CORP. |
K041877 |
07/12/2004 |
ACU-STRAP MOTION SICKNESS BAND |
HEALTH ENT., INC. |
K022645 |
08/08/2002 |
CURAD |
BEIERSDORF AG |
K032463 |
08/11/2003 |
CURAD SILVER BANDAGE |
BEIERSDORF AG |
K032462 |
08/11/2003 |
CURAD SILVER ACTIVE GEL BANDAGE |
BEIERSDORF AG |
K963241 |
08/19/1996 |
ULTRAFLEX |
BOSTON SCIENTIFIC CORP. |
K973113 |
08/20/1997 |
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM |
BOSTON SCIENTIFIC CORP. |
K022895 |
09/03/2002 |
ELCAM STOPCOCKS AND MANIFOLDS |
MEDICAL DEVICE CONSULTANTS, INC. |
K062729 |
09/13/2006 |
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG |
COOK BIOTECH, INC. |
K082682 |
09/15/2008 |
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG |
COOK BIOTECH, INC. |
K033066 |
09/29/2003 |
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM |
XITEC HOLDINGS LLC. |
K973826 |
10/07/1997 |
SPHINCTEROTOME |
BOSTON SCIENTIFIC CORP. |
K042813 |
10/12/2004 |
BIOBEAM NARROW BAND LIGHT THERAPY DEVICES |
LIFE WITHOUT PAIN, LLC |
K042923 |
10/22/2004 |
MD-6W WIRELESS CRITICAL DATA VIEWER |
THE MICROOPTICAL CORPORATION |
K003584 |
11/20/2000 |
NEOLYNX SCREENING APPLICATION MANAGER |
MICROMASS, INC. |
K955347 |
11/21/1995 |
ULTRAFLEX |
BOSTON SCIENTIFIC CORP. |
K964937 |
12/10/1996 |
A LITHOTRIPTER-COMPATIBLE BASKET |
BOSTON SCIENTIFIC CORP. |
K965147 |
12/23/1996 |
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS |
BOSTON SCIENTIFIC CORP. |
K970537 |
02/12/1997 |
REXTON MODEL 48 AND 49PP |
REXTON, INC. |
K970372 |
01/31/1997 |
GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS |
PRECISION ENDOSCOPY OF AMERICA, INC. |
K111606 |
06/09/2011 |
PINNACLE PRECISION ACCESS SYSTEM |
TERUMO MEDICAL CORP. |
K102008 |
07/16/2010 |
GLIDESHEATH |
TERUMO MEDICAL CORP. |
K062215 |
08/01/2006 |
CONFIDANT 2.0 |
CONFIDANT INC. |
K112382 |
08/18/2011 |
TERUMO ASPRIATION CATHETER |
Terumo Medical Corporation |
K072698 |
09/24/2007 |
CONFIDANT 2.5 |
CONFIDANT INC. |
K122980 |
09/26/2012 |
GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ |
Terumo Medical Corporation |
K083331 |
11/12/2008 |
CONFIDANT, MODEL 2.6 |
CONFIDANT INC. |
K180571 |
03/05/2018 |
GammaPod |
Xcision Medical Systems, LLC |
K171029 |
04/06/2017 |
eCareCoordinator |
Visicu Inc. |
K171322 |
05/05/2017 |
eCareManager 4.1 |
Visicu, Inc. |
K172706 |
09/07/2017 |
GammaPod - Model A |
Xcision Medical Systems, LLC |
K050922 |
04/13/2005 |
ANS SCS ACCESSORY KIT |
ADVANCED NEUROMODULATION SYSTEMS |
K032751 |
09/05/2003 |
MODIFICATION TO RENEW LEAD EXTENSION |
ADVANCED NEUROMODULATION SYSTEMS |
K033429 |
10/28/2003 |
LAMITRODE SPINAL CORD STIMULATION LEADS |
ADVANCED NEUROMODULATION SYSTEMS |
K053250 |
11/21/2005 |
ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT |
ADVANCED NEUROMODULATION SYSTEMS |
K220853 |
03/23/2022 |
PicoWay Laser System |
Candela Corporation |
K230990 |
04/06/2023 |
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) |
Candela Corporation |
K231392 |
05/12/2023 |
NaviNetics Reusable Stereotactic System (NN1000) |
NaviNetics Inc. |
K221322 |
05/06/2022 |
CUSTMBITE Snoring System |
Dental Choice Holdings LLC |
K222237 |
07/26/2022 |
Cala kIQ |
Cala Health, Inc. |
K223049 |
09/29/2022 |
CardioSTAT« ECG Test Solution |
Icentia Inc. |
K223927 |
12/30/2022 |
360CAS |
Kico Knee Innovation Company Pty Limited |
K190876 |
04/04/2019 |
mCare«Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed |
Mercator Medical (Thailand) LTD. |
K200967 |
04/10/2020 |
mCare(R) Powder Free Nitrile Orange Examination Gloves |
Mercator Medical (Thailand) LTD. |
K172930 |
09/25/2017 |
mCare Powder-free Blue Nitrile Examination Gloves |
Mercator Medical (Thailand) LTD. |
K060388 |
02/14/2006 |
TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT |
AIRWAY MANAGEMENT INC. |
K061732 |
06/20/2006 |
TAP-T |
AIRWAY MANAGEMENT INC. |
K062951 |
09/29/2006 |
TAP III ANTI-SNORING DEVICE |
AIRWAY MANAGEMENT INC. |
K211374 |
05/04/2021 |
Proclean - Nitrile Powder Free Examination Gloves |
Dr.Boo Company Limited |
K010111 |
01/12/2001 |
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK |
MEDICAL ANALYSIS SYSTEMS, INC. |
K011548 |
05/18/2001 |
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
K011731 |
06/05/2001 |
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
K082139 |
07/29/2008 |
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 |
EDWARDS LIFESCIENCES, LLC. |
K103520 |
11/30/2010 |
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING |
EDWARDS LIFESCIENCES, LLC. |
K201268 |
05/12/2020 |
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) |
Plexus Optix, Inc. |
K131193 |
04/26/2013 |
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM |
TACTILE SYSTEMS TECHNOLOGY INC |
K020132 |
01/15/2002 |
CHASE CARDIOVASCULAR PATCH KIT |
CHASE MEDICAL, INC. |
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01/23/2002 |
CHASE CARDIOVASCULAR PATCH KIT |
CHASE MEDICAL, INC. |
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04/08/2002 |
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CHASE MEDICAL, INC. |
K001662 |
05/31/2000 |
CHASE CARDIOVASCULAR PATCH |
CHASE MEDICAL, INC. |
K022093 |
06/27/2002 |
CHASE CARDIOVASCULAR PATCH KIT |
CHASE MEDICAL, INC. |
K003467 |
11/08/2000 |
CHASE CARDIOVASCULAR PATCH |
CHASE MEDICAL, INC. |
K012248 |
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CHASE CARDIOVASCULAR PATCH |
CHASE MEDICAL, INC. |
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MoMe« ARC Wireless Ambulatory ECG Monitoring and Detection System |
InfoBionic, Inc. |
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02/20/2002 |
APEX INTRAMEDULLARY NAIL SYSTEM |
MAGLY ORTHOPEDICS, LLC |
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05/14/2002 |
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM |
MAGLY ORTHOPEDICS, LLC |
K021662 |
05/20/2002 |
MAGLY 6.5MM CANNULATED SCREWS |
MAGLY ORTHOPEDICS, LLC |
K963937 |
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BrainTemp Neonate System (BTNeo System) |
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09/27/2010 |
TRIMED RADIOCARPAL FUSION SYSTEM |
TRIMED, INC. |
K974040 |
10/24/1997 |
C3 EXTERNAL MALE BLADDER CONTROL DEVICE |
TIMM RESEARCH CO. |
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Hospira, Inc |
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HOSPIRA, INC. |
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Hospira Extension Set |
Hospira, Inc. |
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09/16/2014 |
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HOSPIRA, INC. |
K142974 |
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Hospira, Inc |
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08/18/2009 |
HEM-AVERT PERIANAL STABILIZER |
PLEXUS BIOMEDICAL INC. |
K081151 |
04/23/2008 |
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K202297 |
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MORIA, INC. |
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11/20/2012 |
PRESTO 1000 SYSTEM |
PHYSIOSONICS, INC |
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06/16/2021 |
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12/01/2011 |
CLEARSTART SVM SYSTEM |
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K980187 |
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MLT R694 RUBY LASER SYSTEM |
MEDICAL LASER TECHNOLOGIES LTD. |
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03/18/1999 |
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MEDICAL LASER TECHNOLOGIES LTD. |
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DGH Technology, Inc. |
K213859 |
12/10/2021 |
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Stronghold Group LLC |
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04/24/2013 |
SONICISION STERILIZATION TRAY |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
K141371 |
05/27/2014 |
SONICISION CORDLESS ULTRASONIC DISSECTOR |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
K120931 |
03/27/2012 |
CRITICAL CARE VENTILATOR |
ORICARE, INC. |
K113338 |
11/14/2011 |
MEDICAL AIR COMPRESSOR |
ORICARE, INC. |
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JAS AMYLASE LIQUID REAGENT |
JAS Diagnostics, Inc. |
K971485 |
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TRACE AMERICA, INC. |
K182668 |
09/25/2018 |
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Rapid Reboot Recovery Products, LLC |
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K203552 |
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Rapid Reboot Recovery Products, LLC |
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TRACE AMERICA, INC. |
K960035 |
01/03/1996 |
CARBON DIOXIDE - DST |
TRACE AMERICA, INC. |
K980028 |
01/05/1998 |
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
K980030 |
01/05/1998 |
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
K980026 |
01/05/1998 |
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TRACE AMERICA, INC. |
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02/11/2002 |
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JAS Diagnostics, Inc. |
K961114 |
03/20/1996 |
AST INCORPORATING DST |
TRACE SCIENTIFIC LTD. |
K961123 |
03/21/1996 |
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TRACE SCIENTIFIC LTD. |
K961477 |
04/18/1996 |
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TRACE AMERICA, INC. |
K971477 |
04/23/1997 |
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) |
TRACE AMERICA, INC. |
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05/10/2001 |
JAS CALCIUM (ARSENAZO) REAGENT |
JAS Diagnostics, Inc. |
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TRACE AMERICA, INC. |
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05/21/2002 |
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT |
JAS Diagnostics, Inc. |
K011596 |
05/24/2001 |
UREA NITROGEN (BUN) LIQUID REAGENT |
JAS DIAGNOSTIC, INC. |
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05/24/2001 |
ALKALINE PHOSPHATASE LIQUID REAGENT |
JAS Diagnostics, Inc. |
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06/16/1998 |
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT |
TRACE SCIENTIFIC LTD. |
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06/18/2001 |
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JAS Diagnostics, Inc. |
K972297 |
06/19/1997 |
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
K012038 |
06/29/2001 |
JAS URIC ACID LIQUID REAGENT |
JAS Diagnostics, Inc. |
K962723 |
07/15/1996 |
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN |
TRACE AMERICA, INC. |
K012332 |
07/23/2001 |
JAS CARBON DIOXIDE LIQUID REAGENT |
JAS Diagnostics, Inc. |
K962890 |
07/24/1996 |
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) |
TRACE SCIENTIFIC LTD. |
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07/30/2002 |
LDL CHOLESTEROL (AUTOMATED) |
JAS Diagnostics, Inc. |
K953971 |
08/23/1995 |
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY |
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09/24/1997 |
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JAS Diagnostics, Inc. |
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JAS Diagnostics, Inc. |
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11/07/2001 |
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JAS Diagnostics, Inc. |
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11/27/2001 |
CREATINE KINASE (CK-NAC) |
JAS Diagnostics, Inc. |
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12/11/2000 |
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JAS Diagnostics, Inc. |
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12/12/2000 |
JAS MAGNESIUM REAGENT |
JAS Diagnostics, Inc. |
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12/19/2000 |
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02/20/2001 |
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ECHOCATH, INC. |
K993411 |
10/12/1999 |
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR |
MEGA ELECTRONICS LTD. |
K161484 |
05/31/2016 |
ZIIP Device |
ZIIP,LLC |
K212342 |
07/28/2021 |
ZIIP+ Device |
ZIIP, Inc |
K032438 |
08/07/2003 |
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE |
TYCO HEALTHCARE |
K033373 |
10/22/2003 |
MONOJECT INSULIN SYRINGE |
TYCO HEALTHCARE |
K120863 |
03/22/2012 |
WHOLEY GUIDE WIRE SYSTEM |
Covidien LLC |
K092299 |
07/29/2009 |
TRAILBLAZER SUPPORT CATHETER |
EV3 INC |
K162384 |
08/25/2016 |
TrailBlazer Angled Support Catheter |
Medtronic Vascular, Inc.(formerly ev3 Inc.) |
K152188 |
08/05/2015 |
QUAD Dental Implants and Prostheses |
Dentack Impants Ltd |
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02/22/2005 |
ACCU-LEAD |
KENTEC MEDICAL, INC. |
K022506 |
07/30/2002 |
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM |
WIDEMED LTD |
K971191 |
03/31/1997 |
FAR-EAST SHOE COVERS |
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
K971702 |
05/08/1997 |
FAR-EAST BARRIER GOWNS |
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
K954455 |
09/25/1995 |
NIOMED BOUFFANT CAPS |
AMERASIA CORP. |
K954454 |
09/25/1995 |
NIOMED SURGICAL HOOD |
AMERASIA CORP. |
K954747 |
10/16/1995 |
NIOMED BARRIER GOWNS |
AMERASIA CORP. |
K955833 |
12/26/1995 |
NIOMED SURGICAL CAPS |
AMERASIA CORP. |
K022679 |
08/12/2002 |
RAPHAEL |
HAMILTON MEDICAL AG |
K200376 |
02/18/2020 |
Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration |
Navbit Pty Ltd |
K150572 |
03/06/2015 |
Respire Pink Series-Herbst-EF |
Respire Medical Holding |
K152292 |
08/13/2015 |
Respire Blue Series-EF |
Respire Medical Holding |
K214096 |
12/28/2021 |
Respire Clear |
Respire Medical, LLC |
K961337 |
04/08/1996 |
EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM |
MEDISENSE, INC. |
K040684 |
03/16/2004 |
T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 |
SPECTROS CORPORATION |
K970266 |
01/23/1997 |
KENDALL HYDROPHILIC POWDER WOUND DRESSING |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
K990530 |
02/19/1999 |
KERLIX MD ANTIMICROBIAL GAUZE DRESSING |
THE KENDALL COMPANY, L.P. |
K970969 |
03/17/1997 |
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET |
THE KENDAL CO. |
K011283 |
04/27/2001 |
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
THE KENDALL COMPANY |
K961977 |
05/20/1996 |
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
K012736 |
08/16/2001 |
MONOJECT SAFETY NEEDLE |
TYCO HEALTHCARE |
K963446 |
09/03/1996 |
KENDALL DUAL LUMEN CATHETER |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
K973507 |
09/16/1997 |
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
K973511 |
09/17/1997 |
KENDALL CURITY PETROLATUM GAUZE |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
K973619 |
09/23/1997 |
KENDALL CURITY NON-ADHERING DRESSING |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
K973763 |
10/02/1997 |
KENDALL CURITY IODOFORM PACKING STRIP |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
K954706 |
10/12/1995 |
KENDALL BLUNT TUOHY EPIDURAL NEEDLE |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
K013556 |
10/25/2001 |
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE |
TYCO HEALTHCARE |
K964519 |
11/12/1996 |
CURITY THORACENTESIS TRAY |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
K964899 |
12/03/1996 |
KENDALL CURITY URETERAL CATHETER |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
K024010 |
12/04/2002 |
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER |
THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP |
K090135 |
01/21/2009 |
TRIMIRA IDENTAFI 3000 |
REMICALM, LLC |
K000812 |
03/13/2000 |
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) |
NEUROSOFT, INC. |
K000865 |
03/17/2000 |
QUIK-CAP |
NEUROSCAN |
K001324 |
04/26/2000 |
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) |
NEURO SCAN LABS |
K001562 |
05/19/2000 |
NEURO SCAN MEDICAL SYSTEMS A4000 |
NEURO SCAN LABS |
K001563 |
05/19/2000 |
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET |
SCION CARDIOVASCULAR, INC. |
K001564 |
05/19/2000 |
SCAN LT40 (40 CHANNELS) |
NEURO SCAN LABS |
K001692 |
06/02/2000 |
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 |
NEUROSOFT, INC. |
K001781 |
06/13/2000 |
CURRY MULTIMODAL NEUROIMAGING SOFTWARE |
NEUROSOFT, INC. |
K082603 |
09/08/2008 |
TRIMIRA OCS 3000 |
REMICALM, LLC |
K130915 |
04/02/2013 |
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK |
JAS Diagnostics, Inc. |
K001361 |
04/28/2000 |
JILCO TRACTION-FLEXION CHAIR |
JILCO ENTERPRISES |
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06/30/2006 |
MINI-YAG LASER |
AMERICAN LASERS, INC. |
K974142 |
11/03/1997 |
HM-RUBY |
AMERICAN LASERS, INC. |
K970475 |
02/07/1997 |
MM-RUBY |
AMERICAN LASERS, INC. |
K970380 |
02/03/1997 |
F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM |
PYNG MEDICAL CORP. |
K033514 |
11/06/2003 |
CODA CX1 MOTION ANALYSIS SYSTEM |
CHARNWOOD DYNAMICS LTD. |
K033484 |
11/04/2003 |
HUMAN HEART VALVE, CRYOVALVE SG |
CRYOLIFE, INC. |
K062031 |
07/18/2006 |
CHASE CARDIAC ANALYSIS SYSTEM |
CHASE MEDICAL, LP |
K032531 |
08/15/2003 |
CHASE CARDIAC ANALYSIS SYSTEM |
CHASE MEDICAL, INC. |
K072473 |
09/04/2007 |
CHASE MR SYSTEM |
CHASE MEDICAL, LP |
K101797 |
06/28/2010 |
SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO |
K102470 |
08/30/2010 |
LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER |
COVIDIEN, FORMERLY VALLEYLAB, |
K112536 |
09/01/2011 |
SONICISION STERILIZATION TRAY |
COVIDIEN |
K090267 |
02/03/2009 |
SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 |
MIDWEST R.F. LLC. |
K051618 |
06/17/2005 |
SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 |
MIDWEST R.F. LLC. |
K160942 |
04/05/2016 |
Sonablate |
SonaCare Medical, LLC |
K960737 |
02/23/1996 |
MODEL 555 010 XY CONVERSION(55010) |
SYSTEMS SUPPLY SERVICES, INC. |
K022168 |
07/03/2002 |
ENVOY |
MENNEN MEDICAL LTD. |
K163029 |
10/31/2016 |
HydrisÖ Oral Rinse |
BIOPHARM CONSULT, L.L.C. |
K122875 |
09/19/2012 |
ORICARE L2700 |
ORICARE, INC. |
K003756 |
12/06/2000 |
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES |
BIONX IMPLANTS, INC. |
K050695 |
03/18/2005 |
FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT |
DAAVLIN DISTRIBUTING CO. |
K042502 |
09/14/2004 |
3 SERIES PHOTOTHERAPY CABINET |
DAAVLIN DISTRIBUTING CO. |
DEN150011 |
03/23/2015 |
Sonablate 450 |
SonaCare Medical, LLC. |
K150130 |
01/21/2015 |
Ascendant TM Cervical Spacer System |
EXACTECH, INC. |
K150152 |
01/23/2015 |
The Octane Straight Intervertebral Fusion Device, Ti Coated |
EXACTECH, INC. |
K160697 |
03/14/2016 |
Gibralt« Spine System and Gibralt« Occipital Spine System |
Exactech, Inc. |
K143576 |
12/17/2014 |
Exactech Ambassador |
EXACTECH, INC. |
K140551 |
03/04/2014 |
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR |
PERKINELMER, INC. |
K161942 |
07/15/2016 |
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector |
PERKINELMER, INC. |
K161966 |
07/18/2016 |
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector |
PerkinElmer, Inc. |
K142698 |
09/22/2014 |
PerkinElmer, XRpad 4343 F MED Flat Panel Detector |
PerkinElmer, Inc |
K140617 |
03/11/2014 |
PINIT SMALL BONE FUSION SYSTEM |
ARTHROSURFACE, INC. |
K130859 |
03/28/2013 |
HAMMERTOE CORRECTION SYSTEM |
ARTHROSURFACE, INC. |
K091196 |
04/23/2009 |
GRS GLENOID RESURFACING SYSTEM |
ARTHROSURFACE, INC. |
K131377 |
05/14/2013 |
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT |
ARTHROSURFACE, INC. |
K071413 |
05/21/2007 |
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM |
ARTHROSURFACE, INC. |
K141920 |
07/16/2014 |
Wrist Hemiarthroplasty System |
ARTHROSURFACE, INC. |
K122334 |
08/02/2012 |
CHECKMATE SMALL BONE FUSION SYSTEM |
ARTHROSURFACE, INC. |
K132496 |
08/09/2013 |
ARTHROSURFACE TOEMOTION |
ARTHROSURFACE, INC. |
K063370 |
11/08/2006 |
CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY |
ARTHROSURFACE, INC. |
K133835 |
12/18/2013 |
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM |
ARTHROSURFACE, INC. |
K113762 |
12/21/2011 |
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM |
ARTHROSURFACE, INC. |
K190261 |
02/08/2019 |
BOSS Toe Fixation System |
Arthrosurface, Inc. |
K170440 |
02/14/2017 |
KISSloc Suture System |
Arthrosurface, Inc |
K200718 |
03/19/2020 |
Arthrosurface WristMotion Total Wrist Arthroplasty System |
Arthrosurface, Inc. |
K181280 |
05/15/2018 |
Patello-Femoral Wave (Kahuna) Arthroplasty System |
Arthrosurface, Inc. |
K161539 |
06/03/2016 |
Arthrosurface Bone Screws |
ARTHROSURFACE, INC. |
K172383 |
08/08/2017 |
Arthrosurface Bone Screws |
Arthrosurface, Inc. |
K152454 |
08/28/2015 |
HemiCAP MTP Resurfacing Hemi-Arthroplasty System |
ARTHROSURFACE, INC. |
K142942 |
10/14/2014 |
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System |
ARTHROSURFACE INC. |
K203375 |
11/16/2020 |
OVOMotion Reverse Shoulder Arthroplasty System |
Arthrosurface Inc. |
K173964 |
12/29/2017 |
OVOMotion Shoulder Arthroplasty System |
Arthrosurface, Inc. |
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08/19/1996 |
REPLIDERM WOUND DRESSING |
ORPHAN MEDICAL, INC. |
K090966 |
04/06/2009 |
AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) |
SVRC INDUSTRIES, INC. |
K150397 |
02/18/2015 |
Divine 9 |
CarraShield Labs, Inc. |
K200074 |
01/14/2020 |
O-arm O2 Imaging System |
Medtronic Inc. |
K021515 |
05/10/2002 |
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER |
MEDICA CORP. |
K141869 |
07/11/2014 |
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT |
HEMEDEX INCORPORATED |
K173664 |
11/29/2017 |
Medtronic O-arm O2 Imaging System |
Medtronic Inc. |
K130942 |
04/04/2013 |
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF |
LEGACY MEDICAL, INC. |
K112511 |
08/30/2011 |
DOBBHOFF DUAL PORT FEEDING TUBE |
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
K073122 |
11/06/2007 |
MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE |
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
K020947 |
03/25/2002 |
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS |
SMITH & NEPHEW, INC. |
K990723 |
03/05/1999 |
DYONICS VARICOSE VEIN ABLATION BLADE |
SMITH & NEPHEW, INC. |
K991323 |
04/19/1999 |
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR |
SMITH & NEPHEW, INC. |
K032680 |
08/29/2003 |
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045 |
SMITH & NEPHEW, INC. |
K994365 |
12/27/1999 |
DYONICS ELECTROBLADE |
SMITH & NEPHEW, INC. |
K171496 |
05/22/2017 |
Tritanium C Anterior Cervical Cage |
STRYKER SPINE |
K030627 |
02/27/2003 |
ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 |
C.R. BARD, INC. |
K203088 |
10/13/2020 |
Infinity Acute Care System (IACS) Monitoring System |
Draeger Medical Systems, Inc. |
K061753 |
06/21/2006 |
SYNTHES (USA) CLAVICLE HOOK PLATES |
SYNTHES (USA) |
K180459 |
02/20/2018 |
VERASENSE for Zimmer Biomet Persona |
OrthoSensor, Inc. |
K193580 |
12/23/2019 |
VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR |
OrthoSensor, Inc. |
K200587 |
03/06/2020 |
VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder |
OrthoSensor, Inc. |
K200665 |
03/13/2020 |
VERASENSE for Stryker Triathlon |
OrthoSensor, Inc. |
K021238 |
04/18/2002 |
FRYE ADJUSTING INSTRUMENT |
FRYE HEALTH SYSTEMS |
K980092 |
01/09/1998 |
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS |
SMITH & NEPHEW, INC. |
K970247 |
01/22/1997 |
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE |
SMITH & NEPHEW, INC. |
K970511 |
02/11/1997 |
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES |
SMITH & NEPHEW, INC. |
K980604 |
02/17/1998 |
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES |
SMITH & NEPHEW, INC. |
K981156 |
03/31/1998 |
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA |
SMITH & NEPHEW, INC. |
K971850 |
05/20/1997 |
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES |
SMITH & NEPHEW, INC. |
K982149 |
06/18/1998 |
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE |
SMITH & NEPHEW, INC. |
K972471 |
07/01/1997 |
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES |
SMITH & NEPHEW, INC. |
K972979 |
08/11/1997 |
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM |
SMITH & NEPHEW, INC. |
K974767 |
12/22/1997 |
SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS LAPAROSCOPES, SNITH & NEPHEW DYONICS HYSTEROSCOPES |
ENDOSCOPY DIVISION |
K050006 |
01/03/2005 |
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO |
C.R. BARD, INC. |
K031000 |
03/31/2003 |
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 |
C.R. BARD, INC. |
K961271 |
04/02/1996 |
USCI COMMANDER SERIES GUIDE WIRES |
C.R. BARD, INC. |
K992373 |
07/15/1999 |
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE |
C.R. BARD, INC. |
K082094 |
07/24/2008 |
BARD PTFE (TEFLON) COATED GUIDE WIRES |
C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION |
K042105 |
08/04/2004 |
CLIPPER DIAGNOSTIC ELECTRODE CATHETER |
BARD ELECTROPHYSIOLOGY |
K993000 |
09/07/1999 |
BARD HYDROPHILIC COATED GUIDE WIRES |
C.R. BARD, INC. |
K983927 |
11/05/1998 |
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT |
ARTERIAL VASCULAR ENGINEERING, INC. |
K984627 |
12/30/1998 |
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER |
ARTERIAL VASCULAR ENGINEERING, INC. |
K060092 |
01/12/2006 |
QUICKCAT EXTRACTION CATHETER |
KENSEY NASH CORP. |
K071264 |
05/04/2007 |
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE |
SYNTHES (USA) |
K091618 |
06/03/2009 |
VITOMATRIX |
ORTHOVITA, INC. |
K061621 |
06/12/2006 |
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS |
SYNTHES (USA) |
K061973 |
07/12/2006 |
SYNTHES 3.5MM SPRING PLATE |
SYNTHES (USA) |
K102545 |
09/03/2010 |
FM-02 BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
K062872 |
09/26/2006 |
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM |
SYNTHES (USA) |
K063049 |
10/04/2006 |
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM |
SYNTHES (USA) |
K083033 |
10/10/2008 |
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
K063181 |
10/19/2006 |
SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM |
SYNTHES (USA) |
K103173 |
10/28/2010 |
VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
K063473 |
11/16/2006 |
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM |
SYNTHES (USA) |
K063790 |
12/22/2006 |
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM |
SYNTHES (USA) |
K100525 |
02/24/2010 |
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 |
SEPPIM S.A.S. |
K963403 |
08/29/1996 |
ACURAY DIGITAL X-RAY |
NEW IMAGE INDUSTRIES, INC. |
K990314 |
02/01/1999 |
MULTI-CURE COMPOSITE CEMENT |
MEDENTAL INTL. |
K980990 |
03/17/1998 |
POLYCARBOXYLATE CEMENT |
MEDENTAL INTL. |
K982191 |
06/22/1998 |
CHEMICAL CURE COMPOSITE WITH ENAMEL BOND |
MEDENTAL INTL. |
K982779 |
08/07/1998 |
MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 |
MEDENTAL INTL. |
K983018 |
08/28/1998 |
ZINC PHOSPHATE CEMENT |
MEDENTAL INTL. |
K001349 |
04/28/2000 |
CARDIOVISE ECG INTERPRETATIVE SOFTWARE |
INOVISE MEDICAL, INC. |
K100263 |
01/28/2010 |
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS |
SEPPIM S.A.S. |
K100547 |
02/25/2010 |
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL |
SEPPIM S.A.S. |
K130765 |
03/20/2013 |
ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II |
ELITECHGROUP |
K110780 |
03/21/2011 |
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II |
ELITECH GROUP |
K110830 |
03/25/2011 |
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH |
ELITECHGROUP |
K141265 |
05/15/2014 |
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT |
ELITECHGROUP |
K111960 |
07/11/2011 |
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS |
ELITECHGROUP |
K111996 |
07/13/2011 |
ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 |
ELITECHGROUP |
K112029 |
07/15/2011 |
ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 |
ELITECHGROUP |
K122083 |
07/16/2012 |
ELITECH CLINICAL SYSTEMS CK NAC SL |
ELITECHGROUP |
K122177 |
07/23/2012 |
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL |
ELITECHGROUP |
K132399 |
08/01/2013 |
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL |
ELITECH GROUP |
K132468 |
08/07/2013 |
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE |
ELITechGroup Epoch Biosciences |
K102647 |
09/14/2010 |
ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... |
ELITECHGROUP VITAL SCIENTIFIC BV |
K122858 |
09/18/2012 |
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II |
ELITECHGROUP |
K112937 |
10/03/2011 |
MRSA/SA ELITE MGB |
ELITECH |
K102993 |
10/08/2010 |
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL |
SEPPIM S.A.S. |
K113269 |
11/04/2011 |
ELITTECH CLINICAL SYSTEMS ALP IFCC SL |
ELITECHGROUP |
K103376 |
11/17/2010 |
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL |
SEPPIM S.A.S. |
K093883 |
12/18/2009 |
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- |
SEPPIM S.A.S. |
K103747 |
12/23/2010 |
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS |
ELITECHGROUP SEPPIM S.A.S. |
K030580 |
02/24/2003 |
SURETEMP PLUS |
WELCH ALLYN, INC. |
K123153 |
10/09/2012 |
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT |
MEDTRONIC IRELAND |
K993071 |
09/14/1999 |
PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 |
PURITAN BENNETT CORP. |
K013814 |
11/16/2001 |
ABSORBENT ANTIMICROBIAL WOUND DRESSING |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
K980155 |
01/16/1998 |
ENDOBUTTON CONTINUOUS LOOP |
SMITH & NEPHEW, INC. |
K980841 |
03/04/1998 |
RCI FIXATION SCREWS |
SMITH & NEPHEW, INC. |
K972599 |
07/14/1997 |
ACUFEX SCREW CANNULA |
SMITH & NEPHEW ENDOSCOPY, INC. |
K992396 |
07/19/1999 |
BIORCI SCREW |
SMITH & NEPHEW ENDOSCOPY, INC. |
K002261 |
07/25/2000 |
MR-III |
SMITH & NEPHEW, INC. |
K984320 |
12/03/1998 |
BIOABSORBABLE INTERFERENCE SCREWS |
SMITH & NEPHEW, INC. |
K220673 |
03/07/2022 |
Sterile Silver Alginate Wound Dressing |
Qingdao Bright Moon Biomedical Materials Co., Ltd. |
K142409 |
08/27/2014 |
Vinyl Co-Polymer Powder Free Examination Gloves |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
K150144 |
01/22/2015 |
VisuCon-F Low Fibrinogen Control Plasma |
AFFINITY BIOLOGICALS INC. |
K110432 |
02/15/2011 |
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN |
AFFINITY BIOLOGICALS INC. |
K051054 |
04/26/2005 |
VISULIZE FACTOR IX ANTIGEN KIT |
AFFINITY BIOLOGICALS INC. |
K091284 |
05/01/2009 |
VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA |
AFFINITY BIOLOGICALS INC. |
K052825 |
10/05/2005 |
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG |
AFFINITY BIOLOGICALS INC. |
K040538 |
03/02/2004 |
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 |
AMERICAN MEDICAL SYSTEMS, INC. |
K130559 |
03/04/2013 |
MOBICATH BI-DIRECTIONAL GUIDING SHEATH |
Greatbatch Medical |
K090713 |
03/18/2009 |
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP |
AMERICAN MEDICAL SYSTEMS, INC. |
K051530 |
06/09/2005 |
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. |
AMERICAN MEDICAL SYSTEMS, INC. |
K081710 |
06/17/2008 |
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE |
AMERICAN MEDICAL SYSTEMS |
K012208 |
07/16/2001 |
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 |
BECKMAN COULTER, INC. |
K122832 |
09/17/2012 |
MOBICATH TRANSSEPTAL NEEDLE |
Greatbatch Medical |
K023093 |
09/18/2002 |
ACCESS HYPERSENSITIVE HTSH ASSAY |
BECKMAN COULTER, INC. |
K023369 |
10/08/2002 |
ACCESS TOTAL T4 ASSAY |
BECKMAN COULTER, INC. |
K023480 |
10/17/2002 |
ACCESS TOTAL BHCG |
BECKMAN COULTER, INC. |
K003259 |
10/18/2000 |
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 |
BECKMAN COULTER, INC. |
K193502 |
12/18/2019 |
TGS Universal Headrest with Mounting Arm |
Stryker ENT |
K001703 |
06/05/2000 |
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE |
ABBOTT VASCULAR INC. |
K051436 |
06/01/2005 |
PRE' VAGINAL LUBRICANT |
INGFERTLITY, LLC |
K072741 |
09/27/2007 |
PRE-VA VAGINAL LUBRICANT |
INGFERTILITY, LLC |
K150767 |
03/24/2015 |
EDOSE |
GUANGZHOU RAYDOSE SOFTWARE TECHNOLOGY., LLC |
K092552 |
08/20/2009 |
CLO-SURPLUS P.A.D. |
SCION CARDIO-VASCULAR, INC. |
K060757 |
03/21/2006 |
INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER |
IRVINE BIOMEDICAL, INC. |
K000824 |
03/14/2000 |
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX |
MEDAMICUS, INC. |
K953734 |
07/17/1995 |
LUMAX(MODIFICATION) |
MEDAMICUS, INC. |
K100918 |
04/02/2010 |
VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 |
PURICORE INC. |
K093155 |
10/06/2009 |
VASHE WOUND CLEANSING SYSTEM |
PURICORE INC. |
K093697 |
11/30/2009 |
VASHE WOUND THERAPY SOLUTION |
PURICORE INC. |
K994097 |
12/03/1999 |
MEDAMICUS EPIDURAL INTRODUCER |
MEDAMICUS, INC. |
K110133 |
01/18/2011 |
EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER |
CREGANNA-TACTX MEDICAL |
K092232 |
07/23/2009 |
MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 |
PURICORE INC. |
K980851 |
03/05/1998 |
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 |
BOSTON SCIENTIFIC CORP. |
K990705 |
03/04/1999 |
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET |
MEDAMICUS, INC. |
K011085 |
04/10/2001 |
GUIDEWIRE INTRODUCER SAFETY NEEDLE |
MEDAMICUS, INC. |
K971911 |
04/28/1997 |
LUMAX CYSTOMETRY ADMINISTRATION TUBE SET |
MEDAMICUS, INC. |
K013120 |
09/18/2001 |
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 |
MEDAMICUS, INC. |
K993850 |
11/12/1999 |
URINALYSIS REAGENT STRIPS (10 PARAMETERS) |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
K021378 |
05/01/2002 |
PORTABLE HDX INTRAORAL X-RAY |
DENTALEZ GROUP |
K962920 |
07/26/1996 |
RENTON SUCTION DEVICE U.S. PATENT*4,767,404 |
R&S SURGICAL, LLC. |
K191493 |
06/05/2019 |
Ventripoint Medical System Plus (VMS+) 3.0 |
Ventripoint Diagnostics, Ltd. |
K173810 |
12/15/2017 |
Ventripoint Medical System Plus (VMS+) |
Ventripoint Diagnostics, Ltd. |
K072402 |
08/27/2007 |
FLEX-STAR V |
CMP INDUSTRIES LLC. |
K072851 |
10/04/2007 |
POLYSTAR 79 DENTURE BASE RESIN |
CMP INDUSTRIES LLC. |
K170375 |
02/07/2017 |
Nobilplast Denture Resin |
CMP Industries LLC |
K170423 |
02/13/2017 |
DentureID Microchip |
CMP Industries LLC |
K101333 |
05/12/2010 |
CRYOCARE CS SURGICAL SYSTEM |
ENDOCARE, INC. |
K203000 |
10/01/2020 |
KeyPrint KeySplint Hard |
Mycone Dental Supply Co. Inc. (DBA Keystone Industries) |
K230716 |
03/15/2023 |
Robotic Graft Delivery Instruments |
Medtronic Sofamor Danek Inc |
K201267 |
05/12/2020 |
Adaptix Interbody System with Titan nanoLOCK Surface Technology |
Medtronic Sofamor Danek |
K211596 |
05/24/2021 |
CD Horizon Spinal System |
Medtronic |
K212428 |
08/04/2021 |
Centerpiece Plate Fixation System |
Medtronic Sofamor Danek |
K163534 |
12/16/2016 |
Lumipulse G FSH-N Calibrators |
Fujirebio Diagnostics, Inc. |
K160090 |
01/15/2016 |
Lumipulse G ROMA |
Fujirebio Diagnostics, Inc. |
K070820 |
03/26/2007 |
ARCHITECT TACROLIMUS: MODEL 1L77 |
FUJIREBIO DIAGNOSTICS, INC. |
K151378 |
05/22/2015 |
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators |
Fujirebio Diagnostics, Inc. |
K151502 |
06/04/2015 |
ARCHITECT ROMA |
Fujirebio Diagnostics, Inc. |
K142895 |
10/03/2014 |
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators |
FUJIREBIO DIAGNOSTICS, INC |
K153145 |
10/30/2015 |
Lumipulse G TP-N Immunoreaction Cartridge Set |
Fujirebio Diagnostics, Inc. |
K163521 |
12/15/2016 |
Lumipulse G LH Calibrators |
FUJIREBIO DIAGNOSTICS, INC |
K090012 |
01/02/2009 |
DISPOSABLE INFUSION SET |
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS |
K100046 |
01/08/2010 |
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
K090062 |
01/09/2009 |
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM |
DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC |
K100079 |
01/12/2010 |
DIGITAL ULTRASOUND SCANNER |
SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD |
K110124 |
01/18/2011 |
FETAL DOPPLER JPD-100S |
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD |
K110156 |
01/19/2011 |
AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, |
CONTEC MEDICAL SYSTEM CO., LTD. |
K120179 |
01/20/2012 |
REACH SURGICAL STAPLERS |
REACH SURGICAL, INC |
K100184 |
01/21/2010 |
FUSTAR STEERABLE INTRODUCERS |
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
K120193 |
01/23/2012 |
ANY VIEW PATIENT MONITORS |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
K120192 |
01/23/2012 |
DISPOSABLE SURGICAL GOWNS |
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD |
K100203 |
01/25/2010 |
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K140229 |
01/30/2014 |
GENERAL SPINAL SYSTEM |
TIANJIN WALKMAN BIOMATERIAL CO., LTD. |
K140249 |
01/31/2014 |
LONG PULSE ND: YAG LASER SYSTEM |
ADVANCED TECHNOLOGY LASER CO., LTD. |
K130301 |
02/07/2013 |
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE) |
ELIMEDICAL DEVICES (FUJIAN) INC. |
K070371 |
02/08/2007 |
FINGERTIP PULSE OXIMETER MD300C |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K120420 |
02/10/2012 |
STERILE BLUNT FOR SINGLE USE |
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD |
K130340 |
02/11/2013 |
LOCKING BONE PLATES AND SCREWS |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
K090361 |
02/12/2009 |
REMOTE INFRARED THERMOMETER, MODEL RC002 |
RYCOM ELECTRON TECHNOLOGY LIMITED |
K110421 |
02/14/2011 |
DISPOSABLE INSULIN SYRINGE |
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD |
K070451 |
02/15/2007 |
ABLE CENTRAL VENOUS CATHETER |
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD |
K110434 |
02/15/2011 |
TRIXEL CO2 LASER |
BEIJING SYNTECH LASER CO., LTD. |
K100386 |
02/16/2010 |
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 |
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
K080438 |
02/19/2008 |
DENTAL UNIT WITH CHAIR |
NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. |
K130410 |
02/19/2013 |
DENTAL UNIT WITH CHAIR |
XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO. |
K110510 |
02/22/2011 |
S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
K090459 |
02/23/2009 |
DISPOSABLE TPE INFUSION SET |
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS |
K100626 |
03/05/2010 |
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
K080684 |
03/10/2008 |
WG-SURGICAL SUTURES WITH NEEDLE |
FOOSIN MEDICAL SUPPLIES INC. |
K090671 |
03/13/2009 |
PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D |
CONTEC MEDICAL SYSTEM CO., LTD. |
K100721 |
03/15/2010 |
LOCKING BONE SCREW MODEL HCQ04, HCZ04 |
CHANGZHOU ORTHMAR MEDICAL INSTRUMENT CO., LTD. |
K100740 |
03/16/2010 |
MD2000B VITAL SIGN MONITOR, MODEL MD2000B |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K130735 |
03/18/2013 |
SYNTHETIC ABSORBABLE SUTURE |
FOOSIN MEDICAL SUPPLIES INC.LTD |
K130737 |
03/18/2013 |
SYNTHETIC ABSORBABLE SUTURE |
FOOSIN MEDICAL SUPPLIES INC.LTD |
K130738 |
03/18/2013 |
ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS |
NANJING MAIDIXIN MEDICAL DEVICE CO., LTD. |
K110774 |
03/21/2011 |
ELECTRONIC SPHYGMOMANOMETER |
CONTEC MEDICAL SYSTEM CO., LTD. |
K110775 |
03/21/2011 |
ELECTRONIC SPHYGMOMANOMETER |
CONTEC MEDICAL SYSTEMS CO., LTD. |
K130908 |
04/01/2013 |
DISPOSABLE SILICONE FOLEY CATHETER |
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD |
K080933 |
04/02/2008 |
HANDHELD ECG MONITOR, MODEL MD100 |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K090936 |
04/02/2009 |
SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A |
CONTEC MEDICAL SYSTEM CO., LTD. |
K090929 |
04/02/2009 |
STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE |
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD |
K140954 |
04/14/2014 |
LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING |
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
K071081 |
04/17/2007 |
CONTACT LENS CASE |
NINGBO KAIDA RUBBER AND PLASTIC TECHNOLOGY CO., LT |
K141024 |
04/21/2014 |
EXTERNAL PULSE OXIMETER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K101127 |
04/22/2010 |
PATIENT MONITOR, MODEL PM50 |
CONTEC MEDICAL SYSTEM CO., LTD. |
K081230 |
04/30/2008 |
TRAUSON INTRAMEDULLARY NAIL |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
K081241 |
05/01/2008 |
WEIGAO EMPTY CARTRIDGE SYRINGE |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
K121312 |
05/01/2012 |
INTRAMEDULLARY NAIL SYSTEM |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
K131262 |
05/03/2013 |
DIGITAL ELECTROCARDIOGRAPHS |
SONOSCAPE COMPANY LIMITED |
K101273 |
05/06/2010 |
DYNAMIC ECG SYSTEM MODEL TLC5000 |
CONTEC MEDICAL SYSTEM CO., LTD. |
K101337 |
05/12/2010 |
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM |
SONOSCAPE COMPANY LIMITED |
K101400 |
05/18/2010 |
LOCKING COMPRESSION PLATE |
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
K141324 |
05/20/2014 |
HONGYU DISPOSABLE SURGICAL DRAPES |
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD |
K141362 |
05/23/2014 |
PULSE OXIMETER CMS50EW |
CONTEC MEDICAL SYSTEMS CO., LTD. |
K141359 |
05/23/2014 |
HARD PACK SYRINGE |
JIANGYIN CAINA TECHNOLOGY CO., LTD |
K131511 |
05/28/2013 |
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR |
CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD |
K081508 |
05/29/2008 |
HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN |
SHENYANG CANTA MEDICAL TECH CO., LTD. |
K131569 |
05/30/2013 |
PG-800A SERIES |
SHENZHEN PANGO ELECTRONIC CO., LTD |
K091580 |
06/02/2009 |
PICA WHOLE BODY MRI SYSTEM |
TIME MEDICAL LIMITED |
K101555 |
06/04/2010 |
CO2 LASER SYSTEM |
ADVANCED TECHNOLOGY LASER CO., LTD. |
K111559 |
06/06/2011 |
SURGICAL MASKS |
SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. |
K071561 |
06/07/2007 |
HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D |
BEIJING NORTH POLE DENTAL HANDPIECE CO., LTD |
K101577 |
06/07/2010 |
MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K091664 |
06/09/2009 |
GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C |
SHENZHEN GSD TECH. CO., LTD. |
K091672 |
06/09/2009 |
DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES |
SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD. |
K091669 |
06/09/2009 |
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III |
XIOAO MDT TECHNOLOGY CO LTD |
K111617 |
06/10/2011 |
PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 |
ACARE TECHNOLOGY CO., LTD. |
K101694 |
06/16/2010 |
HANDHELD PULSE OXIMETER MODEL M800 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
K101692 |
06/16/2010 |
PATIENT MONITOR |
CONTEC MEDICAL SYSTEM CO., LTD. |
K111690 |
06/16/2011 |
DEVINE SPINAL SYSTEM |
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
K081712 |
06/17/2008 |
FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
K131777 |
06/17/2013 |
HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM |
HYPER TECHNOLOGY INC |
K131763 |
06/17/2013 |
TRUSCOPE SERIES PATIENT MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
K131759 |
06/17/2013 |
METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM |
TIANJIN WALKMAN BIOMATERIAL CO., LTD. |
K131762 |
06/17/2013 |
HANDHELD MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
K131857 |
06/24/2013 |
Q-SWITCHED ND:YAG LASER |
BEIJING HONKON TECHNOLOGIES CO., LTD |
K131858 |
06/24/2013 |
DIGITAL ELECTROCARDIOGRAPH |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
K131859 |
06/24/2013 |
MULTIFUNCTIONAL SERIES |
BEIJING HONKON TECHNOLOGIES CO., LTD |
K131876 |
06/24/2013 |
M SERIES PATIENT MONITOR |
MID-LINK CONSULTING CO., LTD |
K121854 |
06/25/2012 |
SYSTEM, X-RAY, STATIONARY |
BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO. |
K131896 |
06/25/2013 |
SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM |
SUZHOU ANKE MEDICAL SYSTEM CO., LTD |
K131897 |
06/25/2013 |
CV3000 HOLTER ANALYSIS SYSTEM |
VALES & HILLS BIOMEDICAL TECH. LTD. |
K131898 |
06/25/2013 |
A SERIES AND Q SERIES PATIENT MONITORS |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
K131900 |
06/25/2013 |
CONTEC ELECTROCARDIOGRAPH |
CONTEC MEDICAL SYSTEM CO., LTD. |
K131941 |
06/27/2013 |
FETAL MONITORS |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
K132078 |
07/05/2013 |
METALLIC INTRAMEDULLARY NAIL SYSTEM |
TIANJIN WALKMAN BIOMATERIAL CO., LTD. |
K101876 |
07/06/2010 |
DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
K101901 |
07/08/2010 |
IPL THERAPY SYSTEM |
BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPMENT |
K141946 |
07/17/2014 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
K112057 |
07/19/2011 |
KDL SYRINGES AND NEEDLE |
SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO., |
K102050 |
07/21/2010 |
Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 |
ADVANCED TECHNOLOGY LASER CO., LTD. |
K141973 |
07/21/2014 |
DIODE LASER HAIR REMOVAL SYSTEM |
BEIJING ANCHORFREE TECHNOLOGY CO., LTD |
K092230 |
07/23/2009 |
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 |
TIME MEDICAL LIMITED |
K112204 |
08/01/2011 |
KDL DISPOSABLE INFUSION SET |
SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD. |
K072145 |
08/02/2007 |
MEDICAL GLOVE SERIES |
ZHANJIANG JIALI GLOVE PRODUCTS CO., LTD |
K142186 |
08/08/2014 |
DIODE LASER HAIR REMOVAL SYSTEM |
SHENZHEN GSD TECH. CO., LTD. |
K072210 |
08/09/2007 |
CHISON, MODEL 8300 |
CHISON MEDICAL IMAGING CO., LTD. |
K102328 |
08/17/2010 |
BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
K132588 |
08/19/2013 |
ADHESIVE ELECTRODES |
TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. |
K112431 |
08/23/2011 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
K082439 |
08/25/2008 |
DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT |
SHANDONG WEIGAO MEDICAL POLYMER CO., LTD |
K112451 |
08/25/2011 |
S8 DIAGNOSTIC ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
K132643 |
08/26/2013 |
UV PHOTOTHERAPY |
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. |
K132642 |
08/26/2013 |
LOCKING PLATE SYSTEM |
BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD |
K082480 |
08/28/2008 |
CONTEC POCKET FETAL DOPPLER |
CONTEC MEDICAL SYSTEM CO., LTD. |
K122712 |
09/04/2012 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
K122710 |
09/04/2012 |
TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND |
SHENZHEN DELICATE ELECTRONICS CO., LTD. |
K132758 |
09/04/2013 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
K132796 |
09/06/2013 |
SUNTOUCH EYE SPEAR |
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
K112602 |
09/07/2011 |
S6 DIAGNOSTIC ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
K112622 |
09/08/2011 |
HANDHELD ECG MONITOR |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K082617 |
09/09/2008 |
TRAUSON GENERAL SPINAL SYSTEM (GSS) |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
K082641 |
09/11/2008 |
FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL |
CONTEC MEDICAL SYSTEM CO., LTD. |
K102669 |
09/16/2010 |
DIODE LASER THERAPY SYSTEM |
CHINA DAHENG GROUP, INC. |
K072635 |
09/18/2007 |
CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1 |
NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD. |
K132943 |
09/19/2013 |
INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE |
SYNAPTIC MEDICAL LIMITED |
K102741 |
09/22/2010 |
ENTERAL FEEDING BAG AND SETS |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
K082787 |
09/23/2008 |
VITAL SIGNS MONITOR, MODEL: MD500B |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K082789 |
09/23/2008 |
G1B PULSE OXIMETER |
GENERAL MEDITECH, INC. |
K072696 |
09/24/2007 |
ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 |
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD |
K122995 |
09/26/2012 |
INTENSE PULSED LIGHT (IPL) SYSTEMS |
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. |
K133028 |
09/26/2013 |
RITHM ID ELECTROPHYSIOLOGY CATHETER |
SYNAPTIC MEDICAL LIMITED |
K072739 |
09/27/2007 |
JIERUI SYRINGES AND NEEDLES |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
K112804 |
09/27/2011 |
FINGERTIP PULSE OXIMETER |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
K112803 |
09/27/2011 |
PATIENT MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
K122994 |
09/27/2012 |
INTRAMEDULLARY NAIL SYSTEM |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
K123004 |
09/27/2012 |
MIRA LASERS |
MIRA LASERS LLC |
K133059 |
09/27/2013 |
INSULIN PEN NEEDLE |
WENZHOU BEIPU SCIENCE & TECHNOLOGY CO., LTD. |
K133058 |
09/27/2013 |
INSULIN PEN NEEDLE |
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD |
K133053 |
09/27/2013 |
MILESTONE SPINAL SYSTEM |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
K112819 |
09/28/2011 |
RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW |
XIAMEN DOUBLE ENGLINE MEDICAL MATERIAL CO., LTD |
K082846 |
09/29/2008 |
APK SPO2 PULSE OXIMETER SENSOR |
APK TECHNOLOGY CO., LTD |
K102823 |
09/29/2010 |
DISPOSABLE BLOOD PRESSURE CUFF |
WUXI MEDICAL INSTRUMENT FACTORY |
K102825 |
09/29/2010 |
BLOOD PRESSURE CUFF |
APK TECHNOLOGY CO., LTD |
K102833 |
09/29/2010 |
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS |
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD |
K102847 |
09/29/2010 |
DISPOSABLE ENDOMETRIAL SUCTION CURETTE |
JIANGSU SUYUN MEDICAL MATERIALS CO., LTD. |
K102842 |
09/29/2010 |
ADHESIVE ELECTRODES |
RENO MEDICAL LIMITED |
K102920 |
10/01/2010 |
ELECTRONIC BLOOD PRESSURE MONITOR |
SHENZHEN PANGO ELECTRONIC CO., LTD |
K072825 |
10/02/2007 |
FINGERTIP PULSE OXIMETER, MODEL MD300I |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K112911 |
10/03/2011 |
FETAL DOPPLER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K102988 |
10/06/2010 |
ELECTRONIC BLOOD PRESURE MONITOR |
SHENZHEN PANGO ELECTRONIC CO., LTD |
K113018 |
10/11/2011 |
APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM |
BEIJING SYNTECH LASER CO., LTD. |
K113091 |
10/19/2011 |
SYRINGES AND NEEDLES |
JIANGYIN CAINA TECHNOLOGY CO., LTD |
K113212 |
11/01/2011 |
DENTAL LASER THERAPY SYSTEM |
CHINA DAHENG GROUP, INC. |
K073127 |
11/06/2007 |
BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
K113281 |
11/07/2011 |
MRI SYTEMS |
SHENZHEN ANKE HIGH-TECH CO., LTD. |
K073159 |
11/08/2007 |
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
K083349 |
11/13/2008 |
BLOOD TRANSFUSION SET |
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS |
K123483 |
11/13/2012 |
DIODE LASER |
BEIJING SYNTECH LASER CO., LTD. |
K133525 |
11/15/2013 |
LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM |
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
K083429 |
11/19/2008 |
I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT |
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD. |
K123578 |
11/20/2012 |
ANTERIOR CERVICAL PLATE SYSTEM |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
K113485 |
11/23/2011 |
ELECTROCARDIOGRAPH |
SHENZHEN CAREWELL ELECTRONICS CO., LTD |
K123616 |
11/23/2012 |
PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM |
SONOSCAPE COMPANY LIMITED |
K083466 |
11/24/2008 |
MD2000A VITAL SIGN MONITOR, MODEL MD2000A |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
K073432 |
12/06/2007 |
TRAUSON BONE PLATE |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
K103587 |
12/07/2010 |
DISPOSABLE BLLOD COLLECTION NEEDLE |
WEIHAI HONGYU MEDICAL DEVICES CO., LTD. |
K073457 |
12/10/2007 |
MSTAR MPD4500 |
XINAOMDT TECHNOLOGY CO., LTD. |
K073454 |
12/10/2007 |
FINGERTIP PULSE OXIMETER, MODEL CMS-50C |
CONTEC MEDICAL SYSTEM CO., LTD. |
K123797 |
12/10/2012 |
NT1D VITAL SIGNS MONITOR |
NEW TECH, INC. |
K123801 |
12/10/2012 |
FINGER PULSE OXIMETER |
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD |
K123816 |
12/12/2012 |
DIGITAL ELECTROCARDIOGRAPHS |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
K103685 |
12/17/2010 |
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA |
BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD. |
K093910 |
12/22/2009 |
IMPROVACUTER GEL & CLOT ACTIVATOR TUBE |
GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. |
K093971 |
12/24/2009 |
DENTAL HANDPIECE |
NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. |
K093984 |
12/24/2009 |
PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 |
TIME MEDICAL LIMITED |
K073614 |
12/26/2007 |
WG-SURGICAL SUTURES WITH NEEDLE |
FOOSIN MEDICAL SUPPLIES INC. |
K133979 |
12/26/2013 |
TENS |
SUNMAS (H.K.) TRADING LIMITED |
K133985 |
12/26/2013 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
K113833 |
12/27/2011 |
VITAL SIGNS MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
K083918 |
12/30/2008 |
ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 |
ADVANCED TECHNOLOGY LASER CO., LTD. |
K083915 |
12/30/2008 |
ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC |
ADVANCED TECHNOLOGY LASER CO., LTD. |
K134011 |
12/30/2013 |
GENERAL SPINAL SYSTEM |
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
K123358 |
10/31/2012 |
PACIFIC PLUS |
MEDTRONIC VASCULAR |
K133539 |
11/18/2013 |
TOTAL ACROSS |
MEDTRONIC VASCULAR |
K103676 |
12/16/2010 |
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL |
FUJIREBIO DIAGNOSTICS, INC. |
K142377 |
08/26/2014 |
The OnControl Bone Marrow Biopsy System by Vidacare |
VIDACARE LLC |
K980512 |
02/10/1998 |
LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW |
WALTER LORENZ SURGICAL, INC. |
K991029 |
03/29/1999 |
RAPIDFLAP CRANIAL CLAMP |
WALTER LORENZ SURGICAL, INC. |
K001238 |
04/18/2000 |
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM |
WALTER LORENZ SURGICAL, INC. |
K972074 |
06/03/1997 |
SUCTION INSTRUMENTATION |
WALTER LORENZ SURGICAL, INC. |
K972322 |
06/20/1997 |
LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES |
WALTER LORENZ SURGICAL, INC. |
K972420 |
06/27/1997 |
LORENZ PECTUS SUPPORT BAR |
WALTER LORENZ SURGICAL, INC. |
K982604 |
07/27/1998 |
LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM |
WALTER LORENZ SURGICAL, INC. |
K002395 |
08/07/2000 |
MODEL 30 CLASSIC PNEUMATONOMETER |
XOMED, INC. |
K973080 |
08/18/1997 |
SURGICAL VASCULAR CLAMP |
WALTER LORENZ SURGICAL, INC. |
K982906 |
08/18/1998 |
LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM |
WALTER LORENZ SURGICAL, INC. |
K992873 |
08/26/1999 |
LORENZ EXTERNAL MANDIBULAR DISTRACTOR |
WALTER LORENZ SURGICAL, INC. |
K992952 |
09/01/1999 |
LORENZ DISTRACTION SYSTEM |
WALTER LORENZ SURGICAL, INC. |
K992961 |
09/02/1999 |
LORENZ SMALL FRAGMENT SYSTEM |
WALTER LORENZ SURGICAL, INC. |
K002972 |
09/22/2000 |
MEROGEL CONTROL GEL ENT SURGICAL DRESSING |
MEDTRONIC XOMED |
K983728 |
10/22/1998 |
LORENZ IMF SCREW |
WALTER LORENZ SURGICAL, INC. |
K060047 |
01/06/2006 |
CARTO RMT EP NAVIGATION SYSTEM V8 |
BIOSENSE WEBSTER, INC. |
K980732 |
02/25/1998 |
3M CDI QUICK-CELLS WITH HEPARIN TREATMENT |
3M HEALTH CARE |
K091789 |
06/17/2009 |
CARTO RMT EP NAVIGATION SYSTEM V8 |
BIOSENSE WEBSTER, INC. |
K002424 |
08/08/2000 |
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K992992 |
09/07/1999 |
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K993038 |
09/10/1999 |
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K042681 |
09/29/2004 |
CARTO RMT EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
K013608 |
10/31/2001 |
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K981911 |
06/01/1998 |
PROFA |
DUNCAN HYND ASSOCIATES, LTD. |
K021934 |
06/12/2002 |
MODIFICATION TO MEDSTATION |
AISOFTW@RE MEDICAL, S.P.A. |
K963186 |
08/14/1996 |
ORTHO 8000 |
INNER VISION MRI LTD. |
K973090 |
08/18/1997 |
MEDSTATION |
PROGRAM S.R.L. |
K002608 |
08/21/2000 |
INVAC |
DUNCAN HYND ASSOCIATES, LTD. |
K033507 |
11/05/2003 |
MRJ |
PARAMED SRL |
K141117 |
04/30/2014 |
EZ-IO INTRAOSSEOUS INFUSION SYSTEM |
VIDACARE LLC |
K072939 |
10/17/2007 |
HE4 EIA, MODEL: 404-10 US |
FUJIREBIO DIAGNOSTICS, INC. |
K103358 |
11/16/2010 |
ROMA (HE4 EIA + ARCHITECT CA 125 II) |
FUJIREBIO DIAGNOSTICS, INC. |
K130343 |
02/11/2013 |
CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS |
CORIN U.S.A. |
K131647 |
06/05/2013 |
TRINITY ACETABULAR SYSTEM |
CORIN USA |
K122305 |
08/01/2012 |
CORIN TRINITY-I ACETABULAR SHELL |
CORIN USA |
K123705 |
12/03/2012 |
TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS |
CORIN USA |
K142761 |
09/25/2014 |
Corin TaperFit Hip Stem |
CORIN USA |
K170501 |
02/21/2017 |
CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver |
ConMed Corporation |
K190516 |
03/04/2019 |
MicroLink All-Suture Button Fixation System (Radiolucent) |
CONMED Corporation |
K190582 |
03/06/2019 |
MicroLink All-Suture Button Fixation System (Radiopaque) |
CONMED Corporation |
K180763 |
03/23/2018 |
CuffLink Implant System Biocomposite |
CONMED Corporation |
K181120 |
04/27/2018 |
2.8 mm/3.3 mm PopLok Suture Anchors |
ConMed Corporation |
K171592 |
05/31/2017 |
CrossFTÖ Knotless Biocomposite Suture Anchor with Disposable Driver |
ConMed Corporation |
K182446 |
09/07/2018 |
TruShot with Y-Knot All-Suture Anchor |
ConMed Corporation |
K182439 |
09/07/2018 |
TruShot with Y-Knot Shallow All-Suture Anchor |
ConMed Corporation |
K182621 |
09/24/2018 |
CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver |
ConMed Corporation |
K152903 |
10/01/2015 |
REVIVAL(TM) Modular Revision Hip Stem |
CORIN USA |
K153725 |
12/28/2015 |
Corin TaperFit Hip Stem |
CORIN USA LIMITED |
K153772 |
12/31/2015 |
Corin TriFit TS Hip |
CORIN USA LIMITED |
K070822 |
03/26/2007 |
ARCHITECT SIROLIMUS ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
K021792 |
05/31/2002 |
BILAYER MATRIX WOUND DRESSING |
INTEGRA LIFESCIENCES CORP. |
K081635 |
06/11/2008 |
INTEGRA MESHED BILAYER WOUND MATRIX |
INTEGRA LIFESCIENCES CORP. |
K041620 |
06/16/2004 |
NEURA WRAP NERVE PROTECTOR |
INTEGRA LIFESCIENCES CORP. |
K072113 |
08/01/2007 |
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 |
INTEGRA LIFESCIENCES CORP. |
K062353 |
08/11/2006 |
MOZAIK BONE REGENERATION MATRIX - PUTTY |
INTEGRA LIFESCIENCES CORPORATION |
K032693 |
09/02/2003 |
DURAGEN PLUS DURAL GRAFT MATRIX |
INTEGRA LIFESCIENCES CORP. |
K063124 |
10/13/2006 |
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS |
INTEGRA LIFESCIENCES CORP. |
K043427 |
12/13/2004 |
DURAGEN II DURAL REGENERATION MATRIX |
INTEGRA LIFESCIENCES CORP. |
K053655 |
12/30/2005 |
TENDON WRAP TENDON PROTECTOR |
INTEGRA LIFESCIENCES CORPORATION |
K990277 |
01/28/1999 |
O-RING ABUTMENT |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
K020524 |
02/19/2002 |
PATIENTNET MONITORING SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
K040559 |
03/03/2004 |
MODIFICATION TO UNITY NETWORK ID |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K032346 |
07/30/2003 |
UNITY NETWORK IS PATIENT VIEWER |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K032369 |
08/01/2003 |
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K052083 |
08/02/2005 |
NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER |
BIOSENSE WEBSTER, INC. |
K033365 |
10/21/2003 |
APEXPRO FH TELEMETRY SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K033672 |
11/24/2003 |
MODIFICATION TO UNITY NETWORK ID |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K960166 |
01/16/1996 |
PERCOR STAT-DL 9.5 FR. 34 & 40CC |
DATASCOPE CORP. |
K955648 |
12/12/1995 |
K-Y PERSONAL LUBRICANT |
ORTHO PHARMACEUTICAL CORP. |
K960379 |
01/26/1996 |
ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE |
HEART TECHNOLOGY MFG., INC. |
K970296 |
01/27/1997 |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER |
BOSTON SCIENTIFIC CORP. |
K030767 |
03/11/2003 |
FIDJI SMALL CEMENT RESTRICTOR |
SPINE NEXT SA |
K030871 |
03/19/2003 |
FIDJI LARGE CEMENT RESTRICTOR |
SPINE NEXT SA |
K031265 |
04/21/2003 |
SHIRAZ-JAVA SPINAL FIXATION SYSTEM |
SPINE NEXT SA |
K954604 |
10/04/1995 |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY |
HEART TECHNOLOGY MFG., INC. |
K033772 |
12/03/2003 |
SHIRAZ-JAVA SPINAL FIXATION SYSTEM |
SPINE NEXT AMERICA |
K033947 |
12/19/2003 |
SHIRAZ POSTERIOR SYSTEM |
SPINE NEXT AMERICA |
K033965 |
12/22/2003 |
SHIRAZ-ANTERIOR SYSTEM |
SPINE NEXT AMERICA |
K140273 |
02/03/2014 |
EQUALIZER OCCLUSION BALLOON CATHETER |
BOSTON SCIENTIFIC CORP. |
K122394 |
08/07/2012 |
RUBICON 18 SUPPORT CATHETER |
BOSTON SCIENTIFIC CORP. |
K132990 |
09/24/2013 |
OCCLUSION BALLOON CATHETER |
BOSTON SCIENTIFIC CORP. |
K001734 |
06/07/2000 |
FOGARTY VALVULOTOME, MODEL 700091 |
EDWARDS LIFESCIENCES, LLC. |
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10/26/2005 |
WIRELESS PHYSIOLOGIC MONITORING SYSTEM |
EDWARDS LIFESCIENCES, LLC. |
K993816 |
11/10/1999 |
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD |
BAXTER EDWARDS |
K053609 |
12/27/2005 |
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
K981789 |
05/20/1998 |
LORENZ PECTUS SUPPORT BAR STABILIZER |
WALTER LORENZ SURGICAL, INC. |
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02/19/2021 |
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System |
Medtronic, Inc. |
K160809 |
03/24/2016 |
Reveal LINQ |
MEDTRONIC, INC. |
K150614 |
03/10/2015 |
Reveal LINQ |
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K221962 |
07/05/2022 |
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K990184 |
01/20/1999 |
AUTOMARQER |
HAMILTON THORNE RESEARCH |
DEN040009 |
08/25/2004 |
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) |
HAMILTON THORNE BIOSCIENCES |
K012805 |
08/21/2001 |
AUTOMARQER |
HAMILTON THORNE RESEARCH |
K120055 |
01/09/2012 |
HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS |
HAMILTON THORNE, INC. |
K050768 |
03/25/2005 |
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 |
HAMILTON THORNE BIOSCIENCES |
K013091 |
09/17/2001 |
ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM |
VON ZEPPELIN GMBH |
K954658 |
10/10/1995 |
PERNECZKY CLIP APPLIER/REMOVER |
VON ZEPPELIN GMBH |
K013136 |
09/19/2001 |
ANEURYSM CLIPS |
GISTLSTRASSE |
K151715 |
06/25/2015 |
T3 Software |
Etiometry, Inc. |
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08/11/2015 |
T3 Software |
ETIOMETRY, INC. |
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09/23/2014 |
T3 Software |
Etiometry, Inc. |
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11/02/2016 |
T3 Software |
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06/29/2018 |
Medline Patient Cables and Lead Wires |
Medline Industries, Inc. |
K191759 |
07/01/2019 |
Medline Quick Switch Valve with ENFit Connector |
Medline Industries, Inc. |
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08/12/2020 |
Medline ENfit OTC Feeding Syringe |
Medline Industries, Inc. |
K172541 |
08/23/2017 |
Medline Catheter Specimen Collector |
Medline Industries, Inc. |
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09/22/2021 |
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe |
Medline Industries, Inc. |
K173113 |
09/29/2017 |
Medline Disposable Electronic Thermometer Probe Cover |
Medline Industries, Inc. |
K183335 |
12/03/2018 |
Medline Poly-Cath Red Polymer Urethral Catheter |
Medline Industries, Inc. |
K183431 |
12/11/2018 |
Medline Digital Rectal Thermometer Sheath |
Medline Industries, Inc. |
K183577 |
12/21/2018 |
Medline Quick-Clear Wand |
Medline Industries, Inc. |
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03/22/2010 |
TIDI FACEMASK |
TIDI PRODUCTS, LLC |
K132953 |
09/20/2013 |
TIDISHEILD |
TIDI PRODUCTS, LLC |
K092580 |
08/21/2009 |
TIDI FACEMASK |
TIDI PRODUCTS,LLC |
K191583 |
06/14/2019 |
PhotonBlade with Smoke Evacuation |
Invuity Inc. |
K140578 |
03/06/2014 |
ARTHROSCOPIC ENERGY SYSTEM |
CONMED CORPORATION |
K220757 |
03/15/2022 |
Argo Knotless SP Anchor |
CONMED Corporation |
K121064 |
04/06/2012 |
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM |
MAKO SURGICAL CORPORATION |
K171725 |
06/12/2017 |
CuffLink Implant System |
CONMED Corporation |
K112507 |
08/30/2011 |
RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM |
MAKO SURGICAL CORPORATION |
K142535 |
09/09/2014 |
ConMed Mixing and Delivery Kit |
CONMED CORPORATION |
K092998 |
09/28/2009 |
CONMED LINVATEC INTERCEPT IMPLANT |
LINVATEC CORP. |
K152969 |
10/08/2015 |
ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY |
CONMED CORPORATION |
K153499 |
12/07/2015 |
EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension |
ConMed Corporation |
K021787 |
05/30/2002 |
VISUCAM |
CARL ZEISS OPHTHALMIC SYSTEMS, INC. |
K100786 |
03/19/2010 |
MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX |
BSD MEDICAL CORP. |
K141785 |
07/02/2014 |
MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES |
BSD MEDICAL CORP. |
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01/12/2004 |
POLYLASE LP |
DDC TECHNOLOGIES, INC. |
K020513 |
02/15/2002 |
EPY-50 |
DDC TECHNOLOGIES, INC. |
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03/09/2001 |
AL-40 |
DDC TECHNOLOGIES, INC. |
K171167 |
04/21/2017 |
Prodigio Stain Powder |
OperArt LLC |
K001947 |
06/26/2000 |
T.I.M.S., VERSION 2.00 |
TOTAL MEDICAL INFORMATION MANAGEMENT SYSTEMS, INC. |
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01/08/2015 |
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GLUSTITCH, INC. |
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02/24/2003 |
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER |
GLUSTITCH, INC. |
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05/30/2007 |
PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 |
GLUSTITCH, INC. |
K013446 |
10/17/2001 |
GLUSITE, MODEL GLU002 |
GLUSTITCH, INC. |
K974097 |
10/30/1997 |
PERIACRYL |
BLACKLOCK MEDICAL PRODUCTS, INC. |
K083752 |
12/17/2008 |
GLUSEAL 90, MODEL GLU9010 |
GLUSTITCH, INC. |
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08/24/2007 |
MPS OXIPORT AND MPS OXIPORT PLUS |
INNERSPACE, INC. |
K113088 |
10/19/2011 |
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) |
INNERSPACE, INC |
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11/14/2008 |
SYNERGY |
INNERSPACE, INC. |
K090602 |
03/05/2009 |
CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS |
CARDIODYNAMICS INTERNATIONAL CORP. |
K971125 |
03/27/1997 |
ENDO SMARTCAP (100501) |
ENDO SMART CAP CO. |
K092429 |
08/07/2009 |
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BYRNE MEDICAL, INC. |
K093665 |
11/25/2009 |
ENDO SMARTCAP |
BYRNE MEDICAL INC. |
K973972 |
10/20/1997 |
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) |
PERFECT EAR |
K093715 |
12/01/2009 |
EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE |
MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL |
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01/31/2006 |
ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM |
ALVEOLUS, INC. |
K140657 |
03/14/2014 |
CUROS RED PORT PROTECTOR |
IVERA MEDICAL, INC. |
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03/24/2011 |
CUROS PORT PROTECTOR |
IVERA MEDICAL |
K121171 |
04/17/2012 |
CUROS TIP |
IVERA MEDICAL, INC. |
K111210 |
04/29/2011 |
T:SLIM (TM) INSULIN DELIVERY SYSTEM |
TANDEM DIABETES CARE, INC. |
K111992 |
07/13/2011 |
CUROS PORT PROTECTOR |
IVERA MEDICAL, INC. |
K122361 |
08/03/2012 |
T:CONNECT DATA MANAGEMENT SYSTEM |
TANDEM DIABETES CARE, INC. |
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01/04/2019 |
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs |
Ansell Healthcare Products, LLC. |
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01/10/2023 |
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential |
Ansell Healthcare Products, LLC. |
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10/23/2018 |
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs |
Ansell Healthcare Products, LLC. |
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07/12/2010 |
DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 |
MEDSHAPE SOLUTIONS |
K052420 |
09/02/2005 |
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM |
GYNOVA, LLC |
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02/05/1998 |
SURGIN KIT |
SURGIN SURGICAL INSTRUMENTATION, INC. |
K011195 |
04/19/2001 |
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB |
SURGIN SURGICAL INSTRUMENTATION, INC. |
K033182 |
10/01/2003 |
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD |
SURGIN SURGICAL INSTRUMENTATION, INC. |
K033236 |
10/06/2003 |
PRIZM KERATOME BLADE, MODEL MK8512M2 |
SURGIN SURGICAL INSTRUMENTATION, INC. |
K013337 |
10/09/2001 |
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI |
SURGIN INC |
K994015 |
11/26/1999 |
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 |
SURGIN SURGICAL INSTRUMENTATION, INC. |
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12/14/2006 |
JUNIPER COOLING DEVICE XTRA |
JUNIPER MEDICAL INC. |
K090268 |
02/03/2009 |
SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION |
SHIMADZU CORP. |
K090578 |
03/03/2009 |
SHIMADZU COLLIMATOR R-30H |
SHIMADZU CORP. |
K080701 |
03/11/2008 |
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION |
SHIMADZU CORP. |
K101039 |
04/14/2010 |
SHIMADZU COLLIMATOR R-300 |
SHIMADZU CORP. |
K131075 |
04/17/2013 |
X-RAY TV SYSTEM SONIAL VISION G4 |
SHIMADZU CORP. |
K071289 |
05/08/2007 |
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO |
SHIMADZU MEDICAL SYSTEMS |
K071291 |
05/08/2007 |
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 |
SHIMADZU MEDICAL SYSTEMS |
K071287 |
05/08/2007 |
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO |
SHIMADZU MEDICAL SYSTEMS |
K072006 |
07/23/2007 |
DAR-9400F |
SHIMADZU CORP. |
K082224 |
08/06/2008 |
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC |
SHIMADZU MEDICAL SYSTEMS |
K962449 |
06/24/1996 |
OSTEO COMPACTION KIT |
STERI-OSS, INC. |
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08/08/1996 |
STERI-OSS TEMPORARY IMPLANT CEMENT |
STERI-OSS, INC. |
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08/11/1997 |
STERI-OSS UNTIL IMPLANT CEMENT |
STERI-OSS, INC. |
K002475 |
08/11/2000 |
REPLACE TPS COATED IMPLANTS |
NOBEL BIOCARE UAS INC |
K042495 |
09/14/2004 |
CUMULASE |
HALOZYME THERAPEUTICS INC. |
K963897 |
09/27/1996 |
STERI-OSS SINUS AUGMENTATION KIT |
STERI-OSS, INC. |
K963945 |
10/02/1996 |
STERI-OSS GOLD ATTACHMENT SYSTEM |
STERI-OSS, INC. |
K983714 |
10/21/1998 |
SOLARTEC SOURCE 270, MODEL # 90123 |
COGENT LIGHT TECHNOLOGIES, INC. |
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01/05/2022 |
Vista Ophthalmics Vitrectomy Probe |
Vista Ophthalmics LLC |
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09/13/1995 |
PANASIL IMPRESSION MATERIAL |
ROYDENT DENTAL PRODUCTS, INC. |
K983357 |
09/24/1998 |
MUCOPREN SOFT RELINING SYSTEM |
ROYDENT DENTAL PRODUCTS, INC. |
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GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY |
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UNIMED MEDICAL SUPPLIES INC. |
K960942 |
02/13/1996 |
LATEX PATIENT EXAMINATION GLOVE |
SIAM SEMPERMED CORP. LTD. |
K961602 |
04/04/1996 |
LATEX PATIENT EXAMINATION GLOVE (PINK) |
SIAM SEMPERMED CORP. LTD. |
K961415 |
04/04/1996 |
LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION) |
SIAM SEMPERMED CORP. LTD. |
K981975 |
06/05/1998 |
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED |
SIAM SEMPERMED CORP. LTD. |
K982885 |
08/17/1998 |
PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE |
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
K983612 |
10/14/1998 |
POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES |
SHANGHAI JIATAI PLASTIC PRODUCTS CO., LTD. |
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SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC |
NATIONAL CUSTOM ENT., INC. |
K012262 |
07/18/2001 |
BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC |
NATIONAL CUSTOM ENT., INC. |
K012263 |
07/18/2001 |
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 |
NATIONAL CUSTOM ENT., INC. |
K012264 |
07/18/2001 |
MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC |
NATIONAL CUSTOM ENT., INC. |
K012259 |
07/18/2001 |
MEDFUSION 2001 & 2010, MODEL N7215IWC |
NATIONAL CUSTOM ENT., INC. |
K012266 |
07/18/2001 |
SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 |
NATIONAL CUSTOM ENT., INC. |
K091812 |
06/18/2009 |
FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS |
FRONTIER DEVICES, INC. |
K100205 |
01/25/2010 |
FRONTIER DEVICES NEURO SYSTEM |
FOLSOM METAL PRODUCTS, INC. |
K050884 |
04/07/2005 |
ADAPTER CABLE |
REMINGTON MEDICAL, INC. |
K971968 |
05/28/1997 |
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) |
REMINGTON MEDICAL, INC. |
K972134 |
06/06/1997 |
BAG DECANTER |
REMINGTON MEDICAL, INC. |
K210533 |
02/24/2021 |
Inset Reverse Total Shoulder System |
Shoulder Innovations, Inc. |
K192365 |
08/30/2019 |
Shoulder Innovations Total Shoulder System |
Shoulder Innovations Inc |
K213615 |
11/15/2021 |
Shoulder Innovations Total Shoulder System |
Shoulder Innovations, Inc. |
K173824 |
12/18/2017 |
Humeral Short Stem System |
Shoulder Innovations Inc |
K001121 |
04/07/2000 |
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) |
ENGINEERED MEDICAL TECHNOLOGY, INC. |
K170701 |
03/08/2017 |
GEN_2 and GEN_3 Mechanical Wheelchairs |
Free Wheelchair Mission |
K970479 |
02/07/1997 |
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 |
MEDTRONIC MINIMED |
K990801 |
03/10/1999 |
MINIMED 508 INSULIN PUMP |
MEDTRONIC MINIMED |
K991013 |
03/26/1999 |
MINIMED 407C INFUSION PUMP, MODEL 407C |
MEDTRONIC MINIMED |
K011192 |
04/19/2001 |
COMPRESSIBLE LIMB SLEEVE |
ALLIANCE MEDICAL CORP. |
K991759 |
05/24/1999 |
MAERSK MEDICAL CONTOUR INFUSION SET |
MAERSK MEDICAL A/S |
K972107 |
06/05/1997 |
MINIMED INFUSION PUMP, MODEL 507C |
MEDTRONIC MINIMED |
K991979 |
06/14/1999 |
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321 |
MEDTRONIC MINIMED |
K992300 |
07/08/1999 |
QUICK-SERTER, MODEL 395 |
MEDTRONIC MINIMED |
K012625 |
08/13/2001 |
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS |
ALLIANCE MEDICAL CORP. |
K012652 |
08/13/2001 |
REPROCESSED DYONICS ARTHROSCOPIC BURS |
ALLIANCE MEDICAL CORP. |
K012605 |
08/13/2001 |
REPROCESSED ATHROSCOPICS BURS |
ALLIANCE MEDICAL CORP. |
K012648 |
08/13/2001 |
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
K012645 |
08/13/2001 |
REPROCESSED EBI EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
K012635 |
08/13/2001 |
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS |
ALLIANCE MEDICAL CORP. |
K012603 |
08/13/2001 |
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS |
ALLIANCE MEDICAL CORP. |
K012630 |
08/13/2001 |
REPROCESSED LINVATEC ARTHROSCOPIC BURS |
ALLIANCE MEDICAL, INC. |
K012634 |
08/13/2001 |
REPROCESSED EXTERNAL FIXATION DEVICE |
ALLIANCE MEDICAL, INC. |
K012611 |
08/13/2001 |
REPROCESSED DYONICS ARTHROSCOPIC SHAVERS |
ALLIANCE MEDICAL, INC. |
K012613 |
08/13/2001 |
REPROCSSED LINVATEC SHAVERS |
ALLIANCE MEDICAL, INC. |
K012631 |
08/13/2001 |
REPROCESSED SOFT TISSUE ABLATORS |
ALLIANCE MEDICAL CORP. |
K012623 |
08/13/2001 |
REPROCESSED EXTERNAL FIXATION DEVICE |
ALLIANCE MEDICAL CORP. |
K012708 |
08/14/2001 |
ELECTROPHYSIOLOGY CATHETER |
ALLIANCE MEDICAL CORP. |
K963948 |
10/02/1996 |
MINIMED INSULIN PUMP, MODEL 505 |
MEDTRONIC MINIMED |
K974163 |
11/05/1997 |
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316 |
MEDTRONIC MINIMED |
K023714 |
11/05/2002 |
REPROCESSED EXTERNAL FIXATION DEVICE |
ALLIANCE MEDICAL CORP. |
K964455 |
11/06/1996 |
POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 |
MEDTRONIC MINIMED |
K964456 |
11/06/1996 |
POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367 |
MEDTRONIC MINIMED |
K092851 |
09/16/2009 |
MODEL GDCH-2000 |
GLOBAL DENTAL DIRECT, INC. |
K012422 |
07/30/2001 |
K-ASSAY D-DIMER CONTROLS |
KAMIYA BIOMEDICAL CO. |
K221872 |
06/28/2022 |
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System |
Nova Eye Inc. (Business name Nova Eye Medical) |
K072637 |
09/18/2007 |
DIVO |
A2D IMAGING LLC |
K162042 |
07/25/2016 |
OptiScanner 5000 Glucose Monitoring System |
OPTISCAN BIOMEDICAL CORP. |
K121512 |
05/21/2012 |
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM |
BIO-LOGIC SYSTEMS CORP. |
K973665 |
09/25/1997 |
MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER |
MAGNATONE HEARING AID CORP. |
K973861 |
10/09/1997 |
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 |
MAGNATONE HEARING AID CORP. |
K021681 |
05/22/2002 |
MICROPAQ, MODELS 402, 404 |
WELCH ALLYN PROTOCOL, INC. |
K022453 |
07/26/2002 |
MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM |
WELCH ALLYN PROTOCOL, INC. |
K002725 |
08/31/2000 |
MICROPAQ, MODELS 402 AND 404 |
PROTOCOL SYSTEMS, INC. |
K955573 |
12/07/1995 |
OPTIBLAST INTRAORAL SANDBLASTER |
BUFFALO DENTAL MFG. CO., INC. |
K000485 |
02/14/2000 |
HYDRO2, HS-75 |
INNOVISION, INC. |
K011914 |
06/19/2001 |
HYDRO2, HS-75 |
INNOVISION, INC. |
K992884 |
08/25/1999 |
WHEELCHAIR (MANUAL, NOT ELECTRICAL) |
FOSHAN MACHINERY & EQUIPMENT IMPORT & EXPORT CO. |
K173444 |
11/06/2017 |
Quantitative Total Extensible Imaging (QTxI) |
AIQ Solutions, Inc. |
K150574 |
03/06/2015 |
Modular Power Positioning System |
MOTION CONCEPTS |
K191376 |
05/23/2019 |
Modular Power Standing System |
Motion Concepts |
K182995 |
10/30/2018 |
Bariatric Power Positioning System (BPPS) |
Motion Concepts |
K963528 |
09/04/1996 |
ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) |
ALIMED, INC. |
K210763 |
03/15/2021 |
Inman Digital Clear Aligners |
Inman Orthodontic Laboratories, Inc. |
K040090 |
01/16/2004 |
COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) |
PNEUPAC LTD. |
K090205 |
01/28/2009 |
BCI WW1021 PC APPLICATION |
SMITHS MEDICAL PM, INC. |
K020350 |
02/04/2002 |
BCI 3180 PULSE OXIMETER |
BCI, INC. |
K030407 |
02/07/2003 |
ADVISOR, MODEL 9200 |
BCI, INC. |
K030803 |
03/13/2003 |
PARAPAC 200D TRANSPORT, MODEL V200D |
PNEU PAC, LTD. |
K010770 |
03/14/2001 |
BCI ADVISOR VITAL SIGNS MONITOR (9200) |
BCI, INC. |
K070732 |
03/15/2007 |
BCI AUTOCON 3304 DIGITAL PULSE OXIMETER |
SMITHS MEDICAL PM, INC. |
K020899 |
03/20/2002 |
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D |
PNEU PAC, LTD. |
K991086 |
03/31/1999 |
CAPNOCHECK II, MODEL 8400 |
BCI INTL., INC. |
K011156 |
04/16/2001 |
BCI 3403 SLEEP SCREENING PULSE OXIMETER |
BCI, INC. |
K991410 |
04/22/1999 |
3402 HANDHELD PULSE OXIMETER |
BCI INTL., INC. |
K051322 |
05/20/2005 |
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS |
SMITHS MEDICAL INTERNATIONAL, LTD. |
K071527 |
06/04/2007 |
PNEUPAC VR1 AIR MIX |
SMITHS MEDICAL INTERNATIONAL, LTD. |
K021841 |
06/05/2002 |
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER |
PNEU PAC, LTD. |
K001770 |
06/12/2000 |
BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A |
BCI, INC. |
K013171 |
09/24/2001 |
3420 DIGIT PULSE OXIMETER, MODEL 3420 |
BCI, INC. |
K013862 |
11/21/2001 |
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM |
BCI, INC. |
K083557 |
12/02/2008 |
BCI WW1030 PULSE OXIMETER |
SMITHS MEDICAL PM, INC. |
K083705 |
12/15/2008 |
BCI WW1020 PULSE OXIMETER, MODEL WW1020 |
SMITHS MEDICAL PM, INC. |
K043495 |
12/17/2004 |
BABYPAC |
SMITHS MEDICAL INTERNATIONAL LTD., LUTON |
K083787 |
12/19/2008 |
BCI WW1000 PULSE OXIMETER, MODEL WW1000 |
SMITHS MEDICAL PM, INC. |
K984618 |
12/29/1998 |
BCI MINI-TORR PLUS, MODEL 6004 |
BCI INTL., INC. |
K190075 |
01/16/2019 |
Aurora Evacuator |
Rebound Therapeutics |
K960985 |
02/29/1996 |
SLS-CT |
BIO-IMAGING RESEARCH, INC. |
K991831 |
05/28/1999 |
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 |
BOSTON MEDICAL TECHNOLOGIES, INC. |
K042128 |
08/06/2004 |
MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) |
ZARGIS MEDICAL CORP. |
K080466 |
02/21/2008 |
ALCOHOL PAD |
122 CORPORATION |
K062511 |
08/28/2006 |
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX |
ALVEOLUS, INC. |
K003707 |
12/01/2000 |
CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A |
CARDIONET |
K210401 |
02/10/2021 |
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitril |
Ansell Healthcare Products LLC |
K200671 |
03/13/2020 |
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for |
Ansell Healthcare Products LLC |
K212148 |
07/09/2021 |
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs |
Ansell Healthcare Products LLC |
K022500 |
07/29/2002 |
DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
K022521 |
07/30/2002 |
BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
K040556 |
03/02/2004 |
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY |
EASTMAN KODAK COMPANY |
K181008 |
04/17/2018 |
NuFACE Trinity |
Carol Cole Company dba NuFACE |
K171588 |
05/31/2017 |
NuBODY Skin Toning Device |
Carol Cole Company dba NuFACE |
K182424 |
09/06/2018 |
NuFACE FIX Skin Toning Device |
Carol Cole Company dba NuFACE |
K060155 |
01/20/2006 |
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS |
SPIRE BIOMEDICAL, INC. |
K040509 |
02/27/2004 |
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 |
SPIRE BIOMEDICAL INC |
K021212 |
04/17/2002 |
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS |
SPIRE BIOMEDICAL INC |
K041559 |
06/10/2004 |
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 |
SPIRE BIOMEDICAL INC |
K022000 |
06/19/2002 |
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) |
SPIRE BIOMEDICAL INC |
K032061 |
07/03/2003 |
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH |
SPIRE BIOMEDICAL, INC. |
K022620 |
08/07/2002 |
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT |
SPIRE BIOMEDICAL, INC. |
K022644 |
08/08/2002 |
RETRO REPAIR KIT, MODEL PRRK5 |
SPIRE BIOMEDICAL, INC. |
K013160 |
09/21/2001 |
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER |
SPIRE BIOMEDICAL INC |
K042858 |
10/15/2004 |
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS |
SPIRE BIOMEDICAL, INC. |
K190383 |
02/19/2019 |
GM501 Wash |
Hamilton Thorne, Inc. |
K191552 |
06/12/2019 |
GM501 Mineral Oil |
Hamilton Thorne Inc. |
K202241 |
08/10/2020 |
LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) |
Hamilton Thorne, Inc. |
K192503 |
09/12/2019 |
GM501 Wash with Phenol Red and Gentamicin |
Hamilton Thorne Incorporated |
K192644 |
09/24/2019 |
GM501 SpermAir and GM501 SpermActive |
Hamilton Thorne Incorporated |
K971794 |
05/15/1997 |
ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE |
FRANTZ DESIGN, INC. |
K973884 |
10/14/1997 |
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE |
FRANTZ DESIGN, INC. |
K230063 |
01/09/2023 |
G Surgical Marksman Spinal Deformity System |
G Surgical LLC |
K210890 |
03/25/2021 |
GPS Cervical Spacers |
G Surgical LLC |
K081041 |
04/11/2008 |
GPS, G SURGICAL PEDICLE SYSTEM |
G SURGICAL CO., LTD. |
K161516 |
06/02/2016 |
G Surgical Marksman MIS System |
G SURGICAL LLC |
K171834 |
06/20/2017 |
G Surgical OCT Spinal System |
G Surgical LLC |
K142456 |
09/02/2014 |
GPS Spacers |
G SURGICAL, LLC |
K103070 |
10/18/2010 |
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + |
G SURGICAL CO., LTD. |
K193219 |
11/21/2019 |
G Surgical Marksman System |
G Surgical LLC |
K223217 |
10/17/2022 |
Zynex Monitoring System, Model CM-1600 |
Zynex Medical, Inc. |
K140416 |
02/18/2014 |
TREKKER, TREKKER TRANSIT |
CONVAID PRODUCTS, INC. |
K171017 |
04/05/2017 |
Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T |
Convaid Products llc. |
K032402 |
08/04/2003 |
RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T, |
CONVAID PRODUCTS, INC. |
K050462 |
02/23/2005 |
SBI HAND FIXATION SYSTEM (TM) |
SMALL BONE INNOVATIONS LLC |
K070761 |
03/20/2007 |
SANATMETAL NAILS AND PINS |
SANATMETAL MFR. OF ORTHOPAEDIC/TRAUMATOLOGIC PROD. |
K051605 |
06/16/2005 |
SBI K-WIRES |
SMALL BONE INNOVATIONS, LLC |
K051747 |
06/29/2005 |
SBI WRISTFIT |
SMALL BONE INNOVATIONS, LLC |
K072370 |
08/23/2007 |
SURGICRAFT SURGICAL MESH SYSTEM |
SURGICRAFT LTD. |
K052576 |
09/19/2005 |
SBI AUTOFIX |
SMALL BONE INNOVATIONS, LLC |
K083798 |
12/22/2008 |
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF |
MEDICREA TECHNOLOGIES |
K981329 |
04/13/1998 |
FETH-R-KATH |
EPIMED INTERNATIONAL, INC. |
K110268 |
01/28/2011 |
FORCETRIAD ELECTROSURGICAL GENERATOR |
COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON |
K030464 |
02/12/2003 |
GEM, MODEL 004110 |
COLLINS MEDICAL, INC. |
K030917 |
03/24/2003 |
GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 |
COLLINS MEDICAL, INC. |
K051572 |
06/14/2005 |
KOKO LEGEND |
PULMONARY DATA SERVICES, INC. |
K172509 |
08/21/2017 |
Sentosa SA201 HSV 1/2 Qualitative PCR Test |
Vela Diagnostics USA Inc. |
K982956 |
08/24/1998 |
FLOWMATE II PLUS, MODEL #4000 |
SPIROMETRICS MEDICAL EQUIPMENT CO. |
K954759 |
10/17/1995 |
FLOWMATE LTE |
SPIROMETRICS MEDICAL EQUIPMENT CO. |
K133338 |
10/30/2013 |
LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
K143654 |
12/23/2014 |
Valleylab LS10 Generator |
COVIDIEN LLC |
K982985 |
08/26/1998 |
CITREX HOSPITAL SPRAY DISINFECTANT |
CALTECH INDUSTRIES, INC. |
K101036 |
04/14/2010 |
SHIMADZU COLLIMATOR R-20J |
SHIMADZU CORP. |
K013841 |
11/20/2001 |
3DFIS, MODEL IES-FL-101 |
3DSHARP, INC. |
K051037 |
04/25/2005 |
IMAGEQUBE PACS |
INTUITIVE IMAGING INFORMATICS, LLC |
K031473 |
05/09/2003 |
RATIONAL IMAGING PACS |
INTUITIVE IMAGING INFORMATICS, LLC |
K182793 |
10/01/2018 |
AP3600 Automated Instrument |
Hitachi Chemical Diagnostics, Inc. |
K112910 |
10/03/2011 |
AP 72OS SEMI-AUTOMATED INSTRUMENT |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
K213386 |
10/13/2021 |
Titan Manufacturing Bipolar Forceps |
Titan Manufacturing, Inc. |
K974594 |
12/09/1997 |
SEMKIN BIPOLAR FORCEP |
TITAN MFG., INC. |
K974595 |
12/09/1997 |
CUSHING BAYONET, INSULATED BIPOLAR FORCEP |
TITAN MFG., INC. |
K974593 |
12/09/1997 |
SEMKIN INSULATED BIPOLAR FORCEP |
TITAN MFG., INC. |
K050919 |
04/12/2005 |
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P |
ANALOGIC CORP. |
K052447 |
09/07/2005 |
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 |
ANALOGIC CORP. |
K032824 |
09/10/2003 |
STELKAST UNICONDYLAR KNEE SYSTEM |
STELKAST COMPANY |
K022686 |
08/13/2002 |
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE |
LAP SURGICAL SYSTEMS, LLC |
K981112 |
03/26/1998 |
MOBETRON |
INTRAOP MEDICAL, INC. |
K983869 |
11/02/1998 |
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH |
CALTECH INDUSTRIES, INC. |
K973057 |
08/15/1997 |
1.4 FR MAPCATH SENSOR STYLET |
NAVION BIOMEDICAL CORP. |
K983476 |
10/02/1998 |
BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES |
NAVION BIOMEDICAL CORP. |
K984037 |
11/12/1998 |
CORE-IDE |
ROYDENT DENTAL PRODUCTS, INC. |
K982926 |
08/20/1998 |
FRESENIUS BLOOD VOLUME MONITOR |
FRESENIUS MEDICAL CARE NORTH AMERICA |
K963527 |
09/04/1996 |
UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS |
ALIMED, INC. |
K963526 |
09/04/1996 |
STRAP WEDGE |
ALIMED, INC. |
K013428 |
10/16/2001 |
MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM |
OHIO MEDICAL INSTRUMENT CO., INC. |
K001927 |
06/26/2000 |
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME |
THORATEC LABORATORIES CORP. |
K001926 |
06/26/2000 |
VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES |
THORATEC LABORATORIES CORP. |
K121662 |
06/05/2012 |
VECTTOR VT-200 |
ALAN NEUROMEDICAL TECHNOLOGIES LLC |
K000113 |
01/14/2000 |
PROVEN KNEE SYSTEM |
STELKAST COMPANY |
K960180 |
01/16/1996 |
22 MM COCR HEAD & POLYETHLENE LINER |
STELKAST COMPANY |
K970194 |
01/21/1997 |
PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT |
STELKAST COMPANY |
K010241 |
01/25/2001 |
PROTRACT PRESS FIT HIP STEM-HA COATED |
STELKAST COMPANY |
K980276 |
01/26/1998 |
STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM |
STELKAST COMPANY |
K010282 |
01/30/2001 |
LATERAL OFFSET PROTRACT PRESS FIT HIP STEM |
STELKAST COMPANY |
K970490 |
02/10/1997 |
PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT |
STELKAST COMPANY |
K030577 |
02/24/2003 |
PROVEN MODULAR TIBIAL TRAY |
STELKAST COMPANY |
K960908 |
03/05/1996 |
SRRS PRESSED FIT FEMORAL REVISION COMPONENT |
STELKAST COMPANY |
K010869 |
03/23/2001 |
EPOCA CUSTOM OFFSET SHOULDER SYSTEM |
ARGOMEDICAL AG |
K981451 |
04/22/1998 |
ARGOMEDICAL BIPOLAR SYSTEM |
STELKAST COMPANY |
K991622 |
05/11/1999 |
26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER |
STELKAST COMPANY |
K081458 |
05/23/2008 |
PROVEN STEM EXTENDER |
STELKAST COMPANY |
K001745 |
06/08/2000 |
MODIFICATION TO PROVIDENT HIP SYSTEM |
STELKAST COMPANY |
K021908 |
06/10/2002 |
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL |
STELKAST COMPANY |
K031901 |
06/20/2003 |
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT |
STELKAST COMPANY |
K001984 |
06/29/2000 |
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT |
STELKAST COMPANY |
K032110 |
07/09/2003 |
PROCLASS PRESS FIT HIP STEM |
STELKAST COMPANY |
K953268 |
07/13/1995 |
DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT |
STELKAST COMPANY |
K051976 |
07/21/2005 |
PROVEN REVISION MODULAR TIBIAL TRAY |
STELKAST COMPANY |
K002281 |
07/24/2000 |
STELKAST PROVEN KNEE SYSTEM |
STELKAST COMPANY |
K972961 |
08/11/1997 |
STELKAST BIPOLAR SYSTEM |
STELKAST COMPANY |
K002796 |
09/07/2000 |
MODIFICATION TO PROVIDENT HIP SYSTEM |
STELKAST COMPANY |
K003447 |
11/06/2000 |
PROTRACT PRESS FIT HIP STEM |
STELKAST COMPANY |
K014049 |
12/10/2001 |
EPOCA CODR STEM AND HEAD |
STELKAST COMPANY |
K033944 |
12/19/2003 |
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD |
STELKAST COMPANY |
K094035 |
12/30/2009 |
EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM |
STELKAST COMPANY |
K090811 |
03/25/2009 |
INSPIRA HD, MODEL: NL1000 |
NEUROLOGICA CORPORATION |
K102677 |
09/15/2010 |
BODYTOM NL 4000 |
NEUROLOGICA CORPORATION |
K142399 |
08/27/2014 |
DualCap IV Pole Strips(Disinfectant Caps for Male Luers) |
CATHETER CONNECTIONS, INC. |
K123065 |
10/01/2012 |
CATHETER CONNECTIONS DUALCAP SOLO |
CATHETER CONNECTIONS, INC. |
K112985 |
10/06/2011 |
CATHETER CONNECTIONS' DUALCAP DUO |
CATHETER CONNECTIONS, INC. |
K093229 |
10/14/2009 |
CATHETER CONNECTIONS DUALCAP |
CATHETER CONNECTIONS, INC. |
K123967 |
12/26/2012 |
CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS |
CATHETER CONNECTIONS, INC. |
K113842 |
12/28/2011 |
CATHETER CONNECTIONS' DUALCAP SOLO |
CATHETER CONNECTIONS, INC. |
K970308 |
01/27/1997 |
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE |
MENTOR UROLOGY, INC. |
K010422 |
02/12/2001 |
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER |
INNERSPACE, INC. |
K041838 |
07/07/2004 |
MPS (OR MPS-T) |
INNERSPACE, INC. |
K013005 |
09/06/2001 |
ACT 11 MP VENTRICULAR CATHETER |
INNERSPACE, INC. |
K013705 |
11/08/2001 |
ACT III VENTRICULAR CATHETER |
INNERSPACE, INC. |
K003905 |
12/19/2000 |
ACTI-ICP MONITORING SYSTEM |
INNERSPACE, INC. |
K020294 |
01/28/2002 |
MOTION TRACKING |
ACCURAY, INC. |
K020133 |
01/15/2002 |
MODIFICATION TO THE MAESTRO SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
K020645 |
02/28/2002 |
MODIFICATION TO THE MAESTRO SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
K011675 |
05/30/2001 |
THE AUTOTAC SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
K960410 |
01/29/1996 |
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR |
PERFECT EAR |
K050397 |
02/16/2005 |
VELASMOOTH, SHAPER |
SYNERON MEDICAL LTD. |
K960726 |
02/22/1996 |
EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP |
EVENFLO CO., INC. |
K960727 |
02/22/1996 |
EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT |
EVENFLO CO., INC. |
K032505 |
08/13/2003 |
AIR PRESS MASSAGER |
TELEBRANDS CORP |
K983776 |
10/26/1998 |
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP |
EVENFLO CO., INC. |
K080648 |
03/07/2008 |
TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE |
ORE-MEDIX, LLC |
K030941 |
03/25/2003 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
TORNIER |
K981591 |
05/04/1998 |
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT |
INTERNATIONAL REGULATORY CONSULTANTS |
K991719 |
05/20/1999 |
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS |
MEDIMEX HOLFELD GMBH & CO. |
K011691 |
05/31/2001 |
KIMSTIM AURICULAR ELECTRODE |
KIM INSTITUTE FOR REHABILITATION MEDICINE, P.C. |
K030636 |
02/28/2003 |
C-PORT |
CLINISURG VASCULAR PRODUCTS, LLC |
K091099 |
04/16/2009 |
C-PORT - HP POWER INJECTABLE PORT |
PHS MEDICAL GMBH |
K960799 |
02/27/1996 |
ORTHO-ICE |
ULTIMATE WIREFORMS, INC. |
K974703 |
12/16/1997 |
CARBON FIBER BREAST BOARD |
MEDTEC, INC. |
K974700 |
12/16/1997 |
MATRIX MT-MX3 |
MEDTEC, INC. |
K001052 |
04/03/2000 |
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX |
MED-TEC,INC. |
K021360 |
04/30/2002 |
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 |
MED-TEC,INC. |
K981992 |
06/08/1998 |
ELECTRON WEDGE MODEL MT-EW-1000 |
MED-TEC,INC. |
K031866 |
06/16/2003 |
MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC |
MED-TEC,INC. |
K962622 |
07/05/1996 |
INTRA-ORAL THERMOPLASTIC SHIELD |
MEDTEC, INC. |
K982624 |
07/28/1998 |
MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 |
MED-TEC,INC. |
K023293 |
10/02/2002 |
MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 |
MED-TEC,INC. |
K973842 |
10/08/1997 |
CARBON FIBER CONFORMAL COUCH TOP |
MEDTEC, INC. |
K954705 |
10/12/1995 |
ACRYSTEEL BLOCKING TRAY |
MEDTEC, INC. |
K955236 |
11/14/1995 |
GREEN TEC-2100 |
MEDTEC, INC. |
K013875 |
11/23/2001 |
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE |
MED-TEC,INC. |
K034054 |
12/30/2003 |
PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 |
MED-TEC,INC. |
K990020 |
01/04/1999 |
TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC |
TE ME NA S.A.R.L. |
K970525 |
02/11/1997 |
STATNET |
GORCA SYSTEMS, INC. |
K100613 |
03/04/2010 |
BIOMED WOUND CLEANSER |
BIOMED LABORATORIES, INC |
K011416 |
05/08/2001 |
MUSCLE IMAGING SYSTEM (MIS) |
MILLENNIUM MAGNETIC IMAGING, INC. |
K041367 |
05/24/2004 |
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA |
TOPCON CORP. |
K031831 |
06/13/2003 |
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM |
TOPCON MEDICAL SYSTEMS, INC. |
K960058 |
01/02/1996 |
OXITEMP, 3301T SA |
BCI INTL., INC. |
K970209 |
01/21/1997 |
CAPNOCHECK PLUS |
BCI INTL., INC. |
K980714 |
02/24/1998 |
BCI 3401 HANDHELD PULSE OXIMETER |
BCI INTL., INC. |
K970801 |
03/04/1997 |
BCI MODEL 6004 NIBP MONITOR (6004) |
BCI INTL., INC. |
K020739 |
03/06/2002 |
BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR |
BCI, INC. |
K011177 |
04/17/2001 |
BCI ADVISOR VITAL SIGNS MONITOR (9200) |
BCI, INC. |
K981939 |
06/02/1998 |
AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR |
BCI INTL., INC. |
K962156 |
06/04/1996 |
3304 PULSE OXIMETER |
BCI INTL., INC. |
K031742 |
06/04/2003 |
BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER |
BCI, INC. |
K982279 |
06/30/1998 |
VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 |
BCI INTL., INC. |
K963496 |
09/03/1996 |
OXI TEMP |
BCI INTL., INC. |
K983796 |
10/27/1998 |
6004 NIBP MONITOR WITH TEMPERATURE |
BCI INTL., INC. |
K974697 |
12/16/1997 |
REUSABLE FINGER SENSOR 3444 |
BCI INTL., INC. |
K070829 |
03/26/2007 |
SYNEPIX 4600 DETECTOR |
ANALOGIC CORPORATION |
K040995 |
04/16/2004 |
SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 |
ANALOGIC CORP. |
K071430 |
05/23/2007 |
SYNERAD OMNI, MODELS AN6255 AND AN6265 |
ANALOGIC CORP. |
K041376 |
05/24/2004 |
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A |
ANALOGIC CORP. |
K041434 |
05/28/2004 |
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS |
ANALOGIC CORP. |
K052136 |
08/05/2005 |
GR17 DIGITAL DETECTOR |
ANRAD CORP. |
K042821 |
10/12/2004 |
DIGITAL DETECTOR, MODEL GR17 |
ANRAD CORP. |
K043025 |
11/03/2004 |
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 |
ANALOGIC CORP. |
K171406 |
05/12/2017 |
Optum TeleHealth Application |
United Health Group Inc. |
K980130 |
01/14/1998 |
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM |
RADIOMETER AMERICA, INC. |
K980135 |
01/15/1998 |
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 |
RADIOMETER AMERICA, INC. |
K961355 |
04/08/1996 |
MULTICHECK |
RADIOMETER AMERICA, INC. |
K961354 |
04/08/1996 |
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) |
RADIOMETER AMERICA, INC. |
K962158 |
06/04/1996 |
PICO MODELS 30, 50, 70 |
RADIOMETER AMERICA, INC. |
K952725 |
06/14/1995 |
MULTICHECK |
RADIOMETER AMERICA, INC. |
K962334 |
06/17/1996 |
EML105 ELECTROLYTE METABOLITE ANALYZER |
RADIOMETER AMERICA, INC. |
K973367 |
09/08/1997 |
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM |
RADIOMETER AMERICA, INC. |
K974818 |
12/23/1997 |
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM |
RADIOMETER AMERICA, INC. |
K963917 |
09/30/1996 |
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT |
HOLDEN WALKER CORP. |
K012451 |
08/01/2001 |
PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 |
WELCH ALLYN PROTOCOL, INC. |
K965032 |
12/17/1996 |
THE PERIOSEAL DENTAL IMPLANT |
PERIOSEAL |
K060210 |
01/27/2006 |
MEDIPORT |
MAXANT TECHNOLOGIES, INC. |
K093129 |
10/02/2009 |
ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II |
ILLUMINA, INC. |
K093128 |
10/02/2009 |
ILLUMINA BEADXPRESS SYSTEM |
ILLUMINA, INC. |
K990079 |
01/11/1999 |
FASTSEAL CHEST WOUND DRESSING |
GREENFIELD MEDICAL TECHNOLOGIES, INC. |
K971348 |
04/10/1997 |
FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM |
GREEN FIELD MEDICAL SOURCING, INC. |
K971759 |
05/12/1997 |
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER |
GREEN FIELD MEDICAL SOURCING, INC. |
K952969 |
06/27/1995 |
EIDOS 5003 HOLTER SYSTEM |
NEW PRODUCT DEVELOPMENT, INC. |
K954584 |
10/02/1995 |
RACZ EPIDURAL CATHETER |
MEDIC EVALUATION DEVICES & INSTRUMENTS CORP. |
K021245 |
04/19/2002 |
DEGOTZEN SYNCHRO |
THE GOTZEN GROUP, INC. |
K951942 |
04/26/1995 |
LAST IMAGE HOLD |
INSIGHT SYSTEMS |
K971079 |
03/25/1997 |
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE |
INTERLOGICS, INC. |
K982824 |
08/11/1998 |
X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID |
I.E.D., INC. |
K133062 |
09/27/2013 |
DISCOVERY SYSTEM |
INNOVATIVE VISUAL SYSTEMS |
K971257 |
04/04/1997 |
VTU-1 VACUUM ERECTION SYSTEM |
MCKENNA & CUNEO |
K991268 |
04/13/1999 |
GONOSTAT GONOCOCCAL DETECTION KIT |
SIERRA DIAGNOSTICS |
K971576 |
04/25/1997 |
REJOYN PENILE SUPPORT SYSTEM |
AMERICAN MEDTECH |
K971919 |
05/23/1997 |
EZCHEK/HBA BLOOD COLLECTION KIT |
FLEXSITE DIAGNOSTICS, INC. |
K001810 |
06/15/2000 |
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING |
FLEXSITE DIAGNOSTICS, INC. |
K022110 |
06/28/2002 |
KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. |
KAWASUMI LABORATORIES, INC. |
K964117 |
10/15/1996 |
NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE |
KAWASUMI LABORATORIES CO., LTD. |
K013819 |
11/16/2001 |
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM |
SIERRA DIAGNOSTIC, L.L.C. |
K023917 |
11/25/2002 |
WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR |
KAWASUMI LABORATORIES, INC. |
K974470 |
11/26/1997 |
VTU-E VACUUM ERECTION SYSTEM |
ENCORE, INC. |
K994323 |
12/22/1999 |
KAWASUMI LABORATORIES PHILEBOTOMY SET |
KAWASUMI LABORATORIES CO., LTD. |
K974829 |
12/24/1997 |
NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) |
KAWASUMI LABORATORIES CO., LTD. |
K955887 |
12/28/1995 |
NEWMED ABP-LITE |
NEWMED CORP. |
K083788 |
12/19/2008 |
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR |
ENDO OPTIKS, INC. |
K972464 |
07/01/1997 |
VITALMIX PLUS EMPTY I.V. CONTAINER |
PACIFIC DEVICE, INC. |
K201069 |
04/22/2020 |
VibrantVue Scleral Saline |
Dry Eye Innovations, LLC |
K171950 |
06/29/2017 |
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) |
Visionary Optics LLC |
K223394 |
11/08/2022 |
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) |
Visionary Optics LLC |
K071604 |
06/12/2007 |
ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM |
ALVEOLUS, INC |
K051621 |
06/20/2005 |
ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM |
ALVEOLUS, INC. |
K012241 |
07/17/2001 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 |
CARDIONET, INC |
K973593 |
09/22/1997 |
BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5 |
BRIDGE MEDICAL, INC. |
K003254 |
10/17/2000 |
CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001 |
MISSION MEDICL DEVICES |
K090094 |
01/14/2009 |
ZELTIQ SYSTEM |
ZELTIQ AESTHETICS |
K080118 |
01/17/2008 |
ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE |
ZELTIQ AESTHETICS |
K040131 |
01/21/2004 |
COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM |
NEW STAR LASERS, INC. |
K010316 |
02/02/2001 |
COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM |
COOLTOUCH CORP. |
K060966 |
04/07/2006 |
COOLTOUCH VARIA ND:YAG LASER SYSTEM |
COOLTOUCH, INC. |
K040921 |
04/08/2004 |
COOLTOUCH, MODEL NS 160 |
COOLTOUCH, INC. |
K031184 |
04/15/2003 |
COOL TOUCH 3 |
NEW STAR LASERS, INC. |
K041323 |
05/18/2004 |
PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA |
NEW STAR LASERS, INC. |
K051434 |
06/01/2005 |
COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV |
NEW STAR LASERS, INC. |
K061618 |
06/09/2006 |
COOLTOUCH, MODEL CTEV |
NEW STAR LASERS, INC. |
K031954 |
06/25/2003 |
COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS |
NEW STAR LASERS, INC. |
K062210 |
08/01/2006 |
COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 |
NEW STAR LASERS, INC. |
K002347 |
08/02/2000 |
COOLTOUCH II |
NEW STAR LASERS, INC. |
K072152 |
08/03/2007 |
JUNIPER CLN1 DERMAL COOLING DEVICE |
JUNIPER MEDICAL INC. |
K012982 |
09/05/2001 |
COOLTOUCH VARIZOOM |
NEW STAR LASERS, INC. |
K043046 |
11/04/2004 |
COOLTOUCH, MODEL CT3S |
NEW STAR LASERS, INC. |
K023962 |
11/29/2002 |
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 |
NEW STAR LASERS, INC. |
K003715 |
12/01/2000 |
COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II |
COOLTOUCH CORP. |
K003781 |
12/07/2000 |
COOLTOUCH VARIA-II ND:YAG LASER SYSTEM |
COOLTOUCH CORP. |
K014035 |
12/07/2001 |
COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS |
COOLTOUCH CORP. |
K994273 |
12/20/1999 |
MODEL 1000 HOLMIUM LASER SYSTEM |
NEW STAR LASERS, INC. |
K024259 |
12/23/2002 |
PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 |
NEW STAR LASERS, INC. |
K971457 |
03/28/1997 |
BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED |
ARCAN ORTHOPAEDIC CORP. |
K955927 |
12/22/1995 |
BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION) |
ARCAN ORTHOPAEDIC CORP. |
K052383 |
08/30/2005 |
INNOCURE IMRT FILTER (COMPENSATORS) |
INNOCURE, LLC |
K080447 |
02/19/2008 |
SURGICRAFT SCREW FIXATION SYSTEM |
SURGICRAFT LTD. |
K100516 |
02/23/2010 |
ANYPLUS PEEK CAGES |
GS MEDICAL CO., LTD. |
K091207 |
04/24/2009 |
SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE |
SURGICRAFT LTD. |
K111354 |
05/13/2011 |
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) |
GS MEDICAL CO., LTD. |
K131612 |
06/03/2013 |
ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES |
GS MEDICAL CO., LTD. |
K072415 |
08/28/2007 |
STALIF (TM) C |
SURGICRAFT LTD. |
K112607 |
09/07/2011 |
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... |
SPINEVISION, S.A. |
K073109 |
11/02/2007 |
STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM |
SURGICRAFT LTD. |
K063353 |
11/06/2006 |
CTBOX CERVICAL/LUMBAR TRACTION |
CIRCULAR TRACTION SUPPLY, INC. |
K983500 |
10/06/1998 |
PRO2 CHECK OXYGEN INDICATOR |
MEDICAL TECHNOLOGY SPECIALISTS, INC. |
K210595 |
03/01/2021 |
SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers |
Camber Spine Technologies, LLC |
K211375 |
05/04/2021 |
BlazerÖ Dx-20 Bidirectional Steerable Diagnostic Catheter |
Boston Scientific Corporation |
K211494 |
05/13/2021 |
Polaris X Unidirectional Steerable Diagnostic Catheter |
Boston Scientific Corporation |
K110373 |
02/08/2011 |
TEMPOROMANIBULAR COIL 15 |
ESAOTE S.P.A. |
K161238 |
05/02/2016 |
S-scan |
Esaote S.p.A. |
K151668 |
06/19/2015 |
S-scan |
ESAOTE S.P.A. |
K142421 |
08/28/2014 |
G-scan Brio |
ESAOTE, S.P.A. |
K153039 |
10/19/2015 |
MRI Dynamic Analysis Plus |
Esaote S.p.A. |
K153277 |
11/12/2015 |
6200 Ultrasound System and 6250 Ultrasound System |
Esaote S.p.A. |
K142666 |
09/18/2014 |
Scrambler Therapy MC-5 A Device |
Delta International Services & Logistics S.r.l |
K982300 |
07/01/1998 |
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K983516 |
10/07/1998 |
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K213029 |
09/21/2021 |
Nitrile Examination Gloves (Powder free, Blue) |
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
K090059 |
01/09/2009 |
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM |
SASET (CHENGDU) INC. |
K150537 |
03/03/2015 |
MiNi Internal Implant System |
MEGAGEN IMPLANT CO., LTD |
K151088 |
04/23/2015 |
DMRC Bulk Fill |
DANVILLE MATERIALS, LLC |
K151514 |
06/05/2015 |
Prestige |
DANVILLE MATERIALS LLC |
K152349 |
08/20/2015 |
Star+ VPS Scannable Impression Material |
DANVILLE MATERIALS LLC |
K142886 |
10/02/2014 |
DMRC Self-Cure Bracket Adhesive One Step and Primer |
DANVILLE MATERIALS, LLC. |
K142880 |
10/02/2014 |
DMRC Light Cure Orthodontic Adhesive System |
Daville Materials LLC |
K142881 |
10/02/2014 |
DMRC Dual Cure Orthodontic Band Cement |
DANVILLE MATERIALS, LLC. |
K210023 |
01/04/2021 |
Surgical Face Mask |
Guangdong Winsun Personal Care Products Co.,Ltd |
K220384 |
02/10/2022 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
K200875 |
04/01/2020 |
ArtiSential Laparoscopic Instruments - Electrodes |
LivsMed Inc. |
K212500 |
08/09/2021 |
ArtiSential Trocar |
LivsMed Inc. |
K150076 |
01/14/2015 |
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L |
DONG IL TECHNOLOGY LTD. |
K161566 |
06/06/2016 |
DMS Disposable Subdermal Needle Electrodes |
Daehan Medical Systems Co., Ltd. |
K150002 |
01/02/2015 |
iNSIGHT Color Doppler Ultrasound System |
SASET (CHENGDU) INC. |
K203142 |
10/20/2020 |
Veuron-Brain-pAb |
Heuron Co., Ltd. |
K203279 |
11/06/2020 |
Veuron-Brain-mN1 |
Heuron Co., Ltd. |
K213801 |
12/06/2021 |
Veuron-Brain-pAb2 |
Heuron Co., Ltd. |
K021752 |
05/28/2002 |
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL |
LUCID KOREA CO., LTD |
K211380 |
05/04/2021 |
Elexir |
Nu Eyne Co., Ltd. |
K192773 |
09/30/2019 |
ALLIVE |
Nu Eyne Co., Ltd |
K213629 |
11/17/2021 |
SMILE |
Nu Eyne Co., Ltd. |
K203580 |
12/07/2020 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
K230499 |
02/24/2023 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
K230498 |
02/24/2023 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
K230539 |
02/27/2023 |
ArtiSential Laparoscopic Instruments-Electrodes |
LivsMed Inc. |
K200501 |
02/28/2020 |
ArtiSential Laparoscopic Instrument-Electrodes |
LivsMed Inc. |
K190909 |
04/08/2019 |
ArtiSential Bipolar Fenestrated Forceps |
Livsmed Inc. |
K180657 |
03/13/2018 |
Resin for Temporary Crown & Bridge |
Dentis Co., Ltd. |
K172345 |
08/02/2017 |
IU Implant System |
Warantec Co.,Ltd. |
K172451 |
08/14/2017 |
Dr.MUSIC 3s |
SmartMedicalDevice Co., Ltd. |
K230102 |
01/13/2023 |
Smart double sides wearable breast pump, Electric bilateral breast pump |
Huizhou LVB Maternal And Infant Supplies Co,Ltd. |
K222971 |
09/27/2022 |
ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device |
Smith & Nephew Inc |
K212169 |
07/12/2021 |
Air compression therapy system FO3002 |
Foshan Hongfeng Co., Ltd. |
K192561 |
09/17/2019 |
TRAUS SUS20 |
Saeshin Precision Co., Ltd. |
K200408 |
02/19/2020 |
VitaVitro« Fertilization Medium, VitaVitro« Gamete Buffer Medium, VitaVitro« Flushing Buffer Medium |
Shenzhen VitaVitro Biotech Co.,Ltd. |
K191063 |
04/22/2019 |
1-Step Culture Medium |
Shenzhen VitaVitro Biotech Co., Ltd. |
K212410 |
08/03/2021 |
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium |
Shenzhen VitaVitro Biotech Co.,Ltd. |
K211631 |
05/27/2021 |
Surgical Face Mask |
Macheng Thimble Technology Investment Co., Ltd |
K222475 |
08/16/2022 |
SNOR LOCK |
Solbaro Co., Ltd |
K150773 |
03/24/2015 |
E-CUBE 15 Diagnostic Ultrasound System |
ALPINION MEDICAL SYSTEMS CO., LTD |
K161439 |
05/24/2016 |
E-CUBE 11 |
ALPINION MEDICAL SYSTEMS CO., LTD. |
K121888 |
06/28/2012 |
E-CUBE 15 |
ALPINION MEDICAL SYSTEMS CO., LTD |
K121937 |
07/02/2012 |
E-CUBE INNO |
ALPINION MEDICAL SYSTEMS CO., LTD |
K132687 |
08/28/2013 |
E-CUBE 7 |
ALPINION MEDICAL SYSTEMS CO., LTD |
K142733 |
09/23/2014 |
E-CUBE 5 |
ALPINION MEDICAL SYSTEMS CO., LTD |
K142884 |
10/02/2014 |
E-CUBE 12 |
ALPINION MEDICAL SYSTEMS CO., LTD |
K123610 |
11/21/2012 |
E-CUBE 15 |
ALPINION MEDICAL SYSTEMS CO., LTD |
K123611 |
11/21/2012 |
E-CUBE 7 |
ALPINION MEDICAL SYSTEMS CO., LTD |
K153424 |
11/25/2015 |
E-CUBE i7 |
ALPINION MEDICAL SYSTEMS CO., LTD. |
K201776 |
06/29/2020 |
Foley Balloon Catheter for Urology |
Apollon co., Ltd. |
K142291 |
08/18/2014 |
GMX Series Medical Air/Oxygen Blender |
GENTEC (SHANGHAI) CORPORATION |
K190837 |
04/01/2019 |
Internal Hex Implant System |
EBI Inc. |
K083293 |
11/10/2008 |
VIATRONIX V3D-CARDIAC, REVISION 1.0 |
VIATRONIX, INC. |
K193031 |
10/30/2019 |
EXPD 4343P, EXPD 3643P |
DRTECH Corporation |
K970776 |
03/04/1997 |
LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT |
LIFECORE BIOMEDICAL, INC. |
K965135 |
12/23/1996 |
LIFECORE CONICAL ABUTMENT |
LIFECORE BIOMEDICAL, INC. |
K011494 |
05/15/2001 |
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL |
BIO-RAD |
K972174 |
06/09/1997 |
LYPHOCHEK REMEDI CONTROL |
BIO-RAD |
K011853 |
06/13/2001 |
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 |
BIO-RAD |
K011867 |
06/14/2001 |
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 |
BIO-RAD |
K955153 |
11/13/1995 |
LYPHOCHEK BENZO/TCA CONTROL-SET B |
BIO-RAD |
K120787 |
03/15/2012 |
MERETE LOCKING BONE PLATE SYSTEM III |
MERETE MEDICAL GMBH |
K101939 |
07/12/2010 |
OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM |
MERETE MEDICAL GMBH |
K072251 |
08/13/2007 |
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM |
MERETE MEDICAL GMBH |
K063487 |
11/17/2006 |
MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE |
MERETE MEDICAL GMBH |
K050148 |
01/24/2005 |
MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT |
MENTOR CORPORATION |
K010709 |
03/09/2001 |
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS |
MENTOR CORP. |
K011500 |
05/16/2001 |
MENTOR CONTOUR PROFILE TISSUE EXPANDER |
MENTOR CORP. |
K031767 |
06/09/2003 |
MENTOR OBTAPE TRANS-OBTURATOR TAPE |
MENTOR CORP. |
K042851 |
10/15/2004 |
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT |
MENTOR CORP. |
K122476 |
08/14/2012 |
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT |
ANSELL HEALTHCARE PRODUCTS, LLC |
K122720 |
09/05/2012 |
LIFESTYLES WARM LOVIN PERSONAL LUBRICANT |
ANSELL HEALTHCARE PRODUCTS LLC |
K973811 |
10/07/1997 |
POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) |
ABSOLUTE QUALITY LEADERSHIP, INC. |
K122054 |
07/13/2012 |
LIFESTYLES NATURAL PERSONAL LUBRICANT |
ANSELL HEALTHCARE PRODUCTS, LLC |
K122477 |
08/14/2012 |
LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT |
ANSELL HEALTHCARE PRODUCTS LLC |
K090002 |
01/02/2009 |
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A |
BAXTER HEALTHCARE CORP. |
K060766 |
03/22/2006 |
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 |
OMRON HEALTHCARE, INC. |
K061822 |
06/28/2006 |
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 |
OMRON HEALTHCARE, INC. |
K062043 |
07/19/2006 |
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 |
OMRON HEALTHCARE, INC. |
K965064 |
12/18/1996 |
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON |
ROSTAM LTD. |
K180114 |
01/16/2018 |
AEON Retrieval Bag |
Lexington Medical Inc. |
K171589 |
05/31/2017 |
AEON Endoscopic Stapler |
Lexington Medical Inc. |
K173443 |
11/06/2017 |
AEON Endoscopic Stapler |
Lexington Medical Inc. |
K050453 |
02/22/2005 |
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 |
IVOCLAR VIVADENT, INC. |
K132209 |
07/16/2013 |
IPS E.MAX CAD ABUTMENT SOLUTIONS |
IVOCLAR VIVADENT AG |
K042820 |
10/12/2004 |
SYSTEMP.C&B PLUS |
IVOCLAR VIVADENT, INC. |
K042819 |
10/12/2004 |
TETRIC EVOCERAM |
IVOCLAR VIVADENT, INC. |
K133318 |
10/28/2013 |
ADHESE UNIVERSAL |
IVOCLAR VIVADENT AG |
K103391 |
11/19/2010 |
IVOBASE HYBRID, IVOBASE HIGH IMPACT |
IVOCLAR VIVADENT, INC. |
K103528 |
11/30/2010 |
IPS EMPRESS DIRECT FLOW |
IVOCLAR VIVADENT, INC. |
K033455 |
10/30/2003 |
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 |
BIOMEDICAL LIFE SYSTEMS, INC. |
K040303 |
02/09/2004 |
59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS |
HYDROGEL VISION CORPORATION |
K051430 |
06/01/2005 |
EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) |
HYDROGEL VISION CORPORATION |
K191442 |
05/30/2019 |
Campylobacter Chek |
Techlab, Inc. |
K191456 |
05/31/2019 |
Campylobacter Quik Chek |
Techlab, Inc |
K041390 |
05/25/2004 |
DIAMOND MEDISTIM |
DIAMOND SYSTEMS USA, INC. |
K093942 |
12/22/2009 |
ENSITE VELOCITY SYSTEM V1.3 |
ST. JUDE MEDICAL |
K230483 |
02/23/2023 |
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) |
Passy-Muir, Inc. |
K051342 |
05/23/2005 |
MEDICAL INTERPOROUS |
BONYF AG |
K020809 |
03/13/2002 |
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT |
CORDIS CORP. |
K150670 |
03/16/2015 |
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device |
ETHICON, INC. |
K151200 |
05/05/2015 |
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device |
ETHICON, INC. |
K121442 |
05/15/2012 |
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER |
CORDIS CORPORATION |
K181652 |
06/22/2018 |
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture |
Ethicon, Inc. |
K152096 |
07/28/2015 |
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive |
Ethicon, Inc. |
K152490 |
09/01/2015 |
DERMABOND PRINEO Skin Closure System |
ETHICON, INC. |
K042969 |
10/28/2004 |
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
K023907 |
11/25/2002 |
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER |
CORDIS CORP. |
K133864 |
12/19/2013 |
DERMABOND PRINEO SKIN CLOSURE SYSTEM |
ETHICON, INC. |
K034050 |
12/30/2003 |
CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F |
CORDIS CORPORATION |
K021080 |
04/03/2002 |
NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS |
CARDIOMED SUPPLIES, INC. |
K093708 |
12/02/2009 |
TELIO CAD |
IVOCLAR VIVADENT, INC. |
K101381 |
05/17/2010 |
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS |
INTEGRA LIFESCIENCES CORPORATION |
K092395 |
08/05/2009 |
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM |
INTEGRA LIFESCIENCES CORP. |
K102875 |
10/01/2010 |
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C |
INTEGRA LIFESCIENCES CORPORATION |
K093968 |
12/23/2009 |
OSV II LOW FLOW LOW PRO VALVE |
INTEGRA LIFESCIENCES CORPORATION |
K150678 |
03/16/2015 |
Sysmex Automated Blood Coagulation Analyzer CS-5100 |
Siemens Healthcare Diagnostic Products Gmbh |
K172333 |
08/02/2017 |
Sysmex CS-5100 |
Siemens Healthcare Diagnostics Products GmbH |
K162688 |
09/27/2016 |
Sysmex CS-2100i |
Siemens Healthcare Diagnostics Products GmbH |
K963707 |
09/16/1996 |
NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) |
NELLCOR PURITAN BENNETT, INC. |
K063313 |
11/02/2006 |
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) |
BOSTON SCIENTIFIC CORP. |
K100807 |
03/22/2010 |
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 |
AMERICAN MEDICAL SYSTEMS, INC. |
K181660 |
06/25/2018 |
Acapella Choice Blue Vibratory PEP Device |
Smiths Medical |
K132790 |
09/06/2013 |
INFIX ANTERIOR LUMBAR SYSTEM |
ZIMMER SPINE, INC |
K132894 |
09/16/2013 |
OPTIO-C ANTERIOR CERVICAL SYSTEM |
ZIMMER SPINE, INC. |
K141053 |
04/24/2014 |
OVINE TISSUE MATRIX(OTM) |
TELA BIO, INC. |
K103118 |
10/21/2010 |
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR |
HOYA PHOTONICS, INC. |
K063834 |
12/26/2006 |
REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM |
HOYA CONBIO, INC |
K100910 |
04/01/2010 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
K141444 |
06/02/2014 |
IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL |
Siemens Healthcare Diagnostics Inc. |
K142878 |
10/02/2014 |
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
K143373 |
11/25/2014 |
IMMULITE« 2000 Calcitonin Calibration Verification Material , IMMULITE« 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
K143636 |
12/22/2014 |
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
K093987 |
12/24/2009 |
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 |
Siemens Healthcare Diagnostics Inc. |
K030289 |
01/28/2003 |
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N |
INTEGRA LIFESCIENCES CORP. |
K050492 |
02/28/2005 |
INTEGRA BONE FIXATION SYSTEM |
INTEGRA LIFESCIENCES CORP. |
K071458 |
05/25/2007 |
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS |
INTEGRA LIFESCIENCES CORPORATION |
K022554 |
08/02/2002 |
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM |
INTEGRA NEUROSCIENCES |
K053045 |
10/28/2005 |
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 |
INTEGRA LIFESCIENCES CORPORATION |
K990585 |
02/23/1999 |
INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER |
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
K990652 |
03/01/1999 |
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER |
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
K981327 |
04/13/1998 |
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER |
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
K991853 |
06/01/1999 |
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT |
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
K982249 |
06/26/1998 |
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER |
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
K983832 |
10/30/1998 |
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER |
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
K994254 |
12/17/1999 |
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER |
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI |
K042687 |
09/29/2004 |
ENZYGNOST F+2 (MONOCLONAL) TEST KIT |
DADE BEHRING, INC. |
K050008 |
01/03/2005 |
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER |
MENTOR CORP. |
K980050 |
01/06/1998 |
MENTOR SKIN PROTECTION PAD |
MENTOR CORP. |
K980483 |
02/09/1998 |
MENTOR SUSPEND SLING |
MENTOR CORP. |
K040959 |
04/13/2004 |
MENTOR GENESIS PENILE PROSTHESIS |
MENTOR CORP. |
K981527 |
04/28/1998 |
MENTOR PATHWAY INTRODUCER/DILATOR |
MENTOR CORP. |
K973146 |
08/22/1997 |
MENTOR SUPER ABSORBENT DRAPE |
MENTOR OPHTHALMICS, INC. |
K983065 |
09/02/1998 |
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM |
MENTOR CORP. |
K052440 |
09/06/2005 |
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER |
MENTOR CORPORATION |
K993308 |
10/04/1999 |
MENTOR EVACARE VAGINAL PESSARIES |
MENTOR CORP. |
K053296 |
11/25/2005 |
MENTOR ARIS SUPRAPUBIC SURGICAL KIT |
MENTOR CORPORATION |
K974469 |
11/26/1997 |
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL |
MENTOR CORP. |
K003784 |
12/07/2000 |
MENTOR SELF-CATH PLUS |
MENTOR CORP. |
K053414 |
12/07/2005 |
MENTOR NOVASILK MESH |
MENTOR CORP. |
K003873 |
12/15/2000 |
MENTOR SELF-CATH CLOSED SYSTEM |
MENTOR CORP. |
K004005 |
12/26/2000 |
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) |
MENTOR CORP. |
K020692 |
03/04/2002 |
EMIT 2000 VANCOMYCIN ASSAY |
DADE BEHRING, INC. |
K020845 |
03/15/2002 |
EMIT 2000 VANCOMYCIN CALIBRATORS |
DADE BEHRING, INC. |
K050665 |
03/15/2005 |
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) |
DADE BEHRING, INC. |
K010871 |
03/23/2001 |
TGL FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
K001256 |
04/19/2000 |
CONTROL PLASMA N |
DADE BEHRING, INC. |
K021381 |
05/01/2002 |
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 |
DADE BEHRING, INC. |
K041870 |
07/09/2004 |
N APOLIPOPROTEIN STANDARD SERUM |
DADE BEHRING, INC. |
K022290 |
07/15/2002 |
PROTEIN S AC |
DADE BEHRING, INC. |
K042209 |
08/16/2004 |
CONTROL PLASMA N AND CONTROL PLASMA P |
DADE BEHRING, INC. |
K023141 |
09/20/2002 |
MODIFICATION TO STANDARD HUMAN PLASMA |
DADE BEHRING, INC. |
K023312 |
10/03/2002 |
CONTROL PLASMA P |
DADE BEHRING, INC. |
K023309 |
10/03/2002 |
CONTROL PLASMA N |
DADE BEHRING, INC. |
K993310 |
10/04/1999 |
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH |
DADE BEHRING, INC. |
K970110 |
01/13/1997 |
BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) |
BARD MEDICAL DIV. |
K960517 |
02/05/1996 |
BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER |
C.R. BARD, INC. |
K961248 |
04/01/1996 |
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS |
C.R. BARD, INC. |
K962921 |
07/26/1996 |
BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER |
C.R. BARD, INC. |
K022447 |
07/26/2002 |
BARD ER URETERAL STENT WITH SUTURE |
C.R. BARD, INC. |
K973013 |
08/13/1997 |
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER |
VAS-CATH, INC. |
K963782 |
09/20/1996 |
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS |
C.R. BARD, INC. |
K984084 |
11/16/1998 |
BARDEX LUBRI-SIL FOLEY CATHETER |
BARD MEDICAL DIV. |
K984136 |
11/18/1998 |
BARDEX LUBRI-SIL I.C. FOLEY CATHETER |
BARD MEDICAL DIV. |
K960021 |
01/02/1996 |
CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS |
CALCITEK, INC. |
K970127 |
01/14/1997 |
EDOSSEOUS DENTAL IMPLANT |
SULZER CALCITEK, INC. |
K962106 |
05/31/1996 |
SPLINE DENTAL IMPLANT SYSTEMS |
CALCITEK, INC. |
K962576 |
07/01/1996 |
SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM |
CALCITEK, INC. |
K943604 |
07/25/1994 |
INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM |
CALCITEK, INC. |
K955619 |
12/11/1995 |
5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS |
CALCITEK, INC. |
K020866 |
03/18/2002 |
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM |
ABBOTT DIABETES CARE INC. |
K031260 |
04/21/2003 |
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 |
ABBOTT DIABETES CARE INC. |
K982840 |
08/12/1998 |
BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING |
BOSTON SCIENTIFIC CORP. |
K063112 |
10/11/2006 |
REVLITE Q-SWITCHED ND:YAG LASER |
HOYA CONBIO, INC |
K962928 |
07/29/1996 |
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) |
CAMINO NEUROCARE, INC. |
K963843 |
09/25/1996 |
ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT |
MICRO MOTORS, INC. |
K964145 |
10/17/1996 |
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 |
CRYSTAL MARK, INC. |
K062708 |
09/11/2006 |
QUANTA LITE CELIAC DGP SCREEN |
INOVA DIAGNOSTICS, INC. |
K020110 |
01/11/2002 |
MODIFICATION TO TRELEX MESH SURGICAL MESH |
BOSTON SCIENTIFIC |
K030503 |
02/19/2003 |
MODIFICATION TO CONTOUR POLARIS URETERAL STENT |
BOSTON SCIENTIFIC CORP. |
K040787 |
03/29/2004 |
MODIFICATION TO SURGICAL MESH POLYMERIC |
BOSTON SCIENTIFIC |
K120134 |
01/17/2012 |
IPS E.MAX PRESS MULTI |
IVOCLAR VIVADENT AG |
K060365 |
02/13/2006 |
APEXCAL |
IVOCLAR VIVADENT, INC. |
K060565 |
03/03/2006 |
CONDYLAFORM II NFC |
IVOCLAR VIVADENT, INC. |
K070646 |
03/08/2007 |
ADHESE ONE |
IVOCLAR VIVADENT, INC. |
K120736 |
03/09/2012 |
SR PHONARES II |
IVOCLAR VIVADENT AG |
K090701 |
03/17/2009 |
EMPRESS DIRECT |
IVOCLAR VIVADENT, INC. |
K090704 |
03/17/2009 |
MULTILINK IMPLANT |
IVOCLAR VIVADENT, INC. |
K090826 |
03/26/2009 |
MONOBOND PLUS |
IVOCLAR VIVADENT, INC. |
K060891 |
03/31/2006 |
VIRTUAL |
IVOCLAR VIVADENT, INC. |
K131487 |
05/23/2013 |
FLUOR PROTECTOR S |
IVOCLAR VIVADENT AG |
K061851 |
06/30/2006 |
ZIRKONZAHN ICE |
ZIRKONZAHN GMBH |
K051782 |
07/01/2005 |
BLUEPHASE 16I |
IVOCLAR VIVADENT, INC. |
K071848 |
07/05/2007 |
IPS INLINE POM SYSTEM |
IVOCLAR VIVADENT, INC. |
K012174 |
07/12/2001 |
ERIS LAYERING MATERIALS |
IVOCLAR NORTH AMERICA, INC. |
K132230 |
07/18/2013 |
ICE ZIRKON TRANSLUZENT |
ZIRKONZAHN SRL |
K032470 |
08/11/2003 |
MULTILINK |
IVOCLAR VIVADENT, INC. |
K042847 |
10/15/2004 |
SYSTEMP.CEM |
IVOCLAR VIVADENT, INC. |
K042848 |
10/15/2004 |
FRC POSTEC PLUS |
IVOCLAR VIVADENT, INC. |
K042846 |
10/15/2004 |
SYSTEMP.LINK |
IVOCLAR VIVADENT, INC. |
K123304 |
10/24/2012 |
SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO |
IVOCLAR VIVADENT AG |
K013584 |
10/30/2001 |
EXCITE SELF ETCH |
IVOCLAR VIVADENT, INC. |
K013802 |
11/15/2001 |
FRC POSTEC |
IVOCLAR VIVADENT, INC. |
K103379 |
11/17/2010 |
TELIO CS INLAY & TELIO CS ONLAY |
IVOCLAR VIVADENT, INC. |
K013869 |
11/21/2001 |
SR IVOCRON |
IVOCLAR VIVADENT, INC. |
K123613 |
11/23/2012 |
SYNSPAR ADVANCED |
ARDENT INC |
K013929 |
11/28/2001 |
HELIOMOLAR HB TRANSLUCENT SHADES |
IVOCLAR VIVADENT, INC. |
K014082 |
12/11/2001 |
D.SIGN 53, MODEL NA1012204 |
IVOCLAR VIVADENT, INC. |
K140611 |
03/10/2014 |
TRINICA ANTERIOR LUMBAR PLATE SYSTEM |
ZIMMER SPINE, INC. |
K141500 |
06/06/2014 |
OPTIO-C ANTERIOR CERVICAL SYSTEM |
ZIMMER SPINE, INC. |
K150896 |
04/02/2015 |
Vitality Spinal Fixation System |
ZIMMER SPINE, INC. |
K151031 |
04/17/2015 |
Virage OCT Spinal Fixation System |
ZIMMER SPINE, INC |
K181699 |
06/27/2018 |
Level 1 Convective Warmer |
Smiths Medical ASD, Inc. |
K142752 |
09/24/2014 |
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360║ Spinal Fixatoin System, Title 2 Polyaxial Spinal System |
ZIMMER SPINE, INC. |
K173384 |
10/30/2017 |
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube |
Smiths Medical ADS, Inc. |
K143297 |
11/17/2014 |
Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) |
Zimmer Spine, Inc. |
K143626 |
12/22/2014 |
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Sele |
Zimmer Spine, Inc. |
K173912 |
12/22/2017 |
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Trache |
Smiths Medical ASD, Inc. |
K120053 |
01/06/2012 |
IPS E.MAX PRESS - ABUTMENT SOLUTIONS |
IVOCLAR VIVADENT AG |
K120432 |
02/13/2012 |
TELIO CS CEM IMPLANT |
IVOCLAR VIVADENT AG |
K130436 |
02/21/2013 |
MULTILINK HYBRID ABUTMENT CEMENT |
IVOCLAR VIVADENT AG |
K110756 |
03/18/2011 |
BLUEPHASE STYLE |
IVOCLAR VIVADENT, INC. |
K030922 |
03/24/2003 |
VIVASENS |
IVOCLAR VIVADENT, INC. |
K040795 |
03/29/2004 |
MULTICORE HB; MULTICORE FLOW |
IVOCLAR VIVADENT, INC. |
K090941 |
04/03/2009 |
ADHESE ONE F |
IVOCLAR VIVADENT, INC. |
K091020 |
04/09/2009 |
BLUEPHASE 20I |
IVOCLAR VIVADENT, INC. |
K091019 |
04/09/2009 |
SPEEDCEM |
IVOCLAR VIVADENT, INC. |
K040951 |
04/12/2004 |
SR ADORO |
IVOCLAR VIVADENT, INC. |
K121359 |
05/07/2012 |
IPS 99 ONE AND IPS 99 CERAM |
IVOCLAR VIVADENT AG |
K011490 |
05/15/2001 |
MODIFICATION TO EXCITE |
IVOCLAR NORTH AMERICA, INC. |
K131753 |
06/14/2013 |
MERIDIAN |
AB ARDENT |
K051705 |
06/24/2005 |
IPS E.MAX CAD/IPS E.MAX ZIRCAD |
IVOCLAR VIVADENT, INC. |
K061781 |
06/26/2006 |
MULTILINK SPRINT |
IVOCLAR VIVADENT, INC. |
K101814 |
06/29/2010 |
DIRECT CROWN NATURAL 1 |
CANDULOR USA, INC. |
K111958 |
07/11/2011 |
TETRIC EVOCERAM BULK FILL |
IVOCLAR VIVADENT, INC. |
K062258 |
08/04/2006 |
GENESIS DIODE LASER |
IVOCLAR VIVADENT, INC. |
K072338 |
08/20/2007 |
CERVITEC PLUS |
IVOCLAR VIVADENT, INC. |
K052463 |
09/08/2005 |
PROMETAL HN86 |
PROMETAL TECHNOLOGIES |
K023035 |
09/12/2002 |
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER |
IVOCLAR VIVADENT, INC. |
K122852 |
09/18/2012 |
PHYSIOSTAR NFC |
CANDULOR USA, INC. |
K132984 |
09/24/2013 |
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S |
IVOCLAR VIVADENT, INC. |
K013275 |
10/01/2001 |
ASTRALIS 10, MODELS # 559588, 561859 |
IVOCLAR VIVADENT, INC. |
K013277 |
10/02/2001 |
ASTRALIS 7, MODEL 557545 |
IVOCLAR VIVADENT, INC. |
K093331 |
10/26/2009 |
SR PHONARES NHC |
IVOCLAR VIVADENT, INC. |
K033520 |
11/07/2003 |
BLUEPHASE |
IVOCLAR VIVADENT, INC. |
K103556 |
12/02/2010 |
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) |
IVOCLAR VIVADENT, INC. |
K033773 |
12/03/2003 |
CONCEPT HP ADD-ON; CONCEPT HP ENAMEL |
IVOCLAR VIVADENT AG |
K093744 |
12/04/2009 |
EXCITE F AND EXCITE DSC |
IVOCLAR VIVADENT, INC. |
K024094 |
12/11/2002 |
4 SEASONS |
IVOCLAR VIVADENT, INC. |
K124008 |
12/27/2012 |
IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE |
IVOCLAR VIVADENT, AGIN |
K143575 |
12/17/2014 |
Accu-Dent XD Tray, Accu-Dent XD Syringe |
IVOCLAR VIVADENT, INC. |
K153753 |
12/29/2015 |
TelioCAD Multi |
IVOCLAR VIVADENT, INC. |
K110549 |
02/25/2011 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
K130594 |
03/07/2013 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
K130727 |
03/18/2013 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
K011152 |
04/16/2001 |
VASOTRAC APM205A |
MEDWAVE, INC. |
K141050 |
04/23/2014 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
K101328 |
05/11/2010 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
K101419 |
05/20/2010 |
ENSITE VELOCITY SYSTEM, MODEL EE3000 |
ST. JUDE MEDICAL |
K061557 |
06/05/2006 |
FUSION |
MEDWAVE, INC. |
K101667 |
06/14/2010 |
ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) |
ST. JUDE MEDICAL |
K001898 |
06/22/2000 |
VASOTRAX |
MEDWAVE, INC. |
K082279 |
08/11/2008 |
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 |
ST. JUDE MEDICAL |
K112688 |
09/15/2011 |
ENSITE VELOCITY SYSTEM V.3.0 |
ST. JUDE MEDICAL |
K053185 |
11/14/2005 |
PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM |
MEDWAVE, INC. |
K040860 |
04/02/2004 |
INTEGRA BONE FIXATION SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
K051440 |
06/02/2005 |
MAYFIELD INFINITY SKULL CLAMP |
INTEGRA LIFESCIENCES CORP. |
K980594 |
02/17/1998 |
OSTEONICS FX-CABLELOK GRIP COMPONENTS |
OSTEONICS CORP. |
K980766 |
02/27/1998 |
OSTEONICS ANTEVERTED NECK HA HIP STEMS |
OSTEONICS CORP. |
K971321 |
04/10/1997 |
OSTEO COMPRESSION CONDYLE SCREW SYSTEM |
OSTEONICS CORP. |
K971497 |
04/24/1997 |
OSTEONICS ANTEVERTED NECK HIP STEM |
OSTEONICS CORP. |
K971654 |
05/06/1997 |
OSTEO COMPRESSION HIP SCREW SYSTEM |
OSTEONICS CORP. |
K971778 |
05/14/1997 |
OSTEO SMALL AND MINI BONE SCREWS |
OSTEONICS CORP. |
K962152 |
06/04/1996 |
OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM |
OSTEONICS CORP. |
K972967 |
08/11/1997 |
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT |
OSTEONICS CORP. |
K973406 |
09/09/1997 |
OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT |
OSTEONICS CORP. |
K964304 |
10/29/1996 |
OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY |
OSTEONICS CORP. |
K964544 |
11/13/1996 |
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY |
OSTEONICS CORP. |
K974556 |
12/05/1997 |
OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM |
OSTEONICS CORP. |
K964893 |
12/06/1996 |
HANSSON PIN SYSTEM |
OSTEONICS CORP. |
K974685 |
12/16/1997 |
OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS |
OSTEONICS CORP. |
K121364 |
05/07/2012 |
SHIGA TOXIN QUIK CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
K121411 |
05/11/2012 |
SHIGA TOXIN CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
K103673 |
12/16/2010 |
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
K170728 |
03/09/2017 |
E. HISTOLYTICA QUIK CHEK |
TECHLAB, Inc. |
K171078 |
04/11/2017 |
TRI-COMBO PARASITE SCREEN |
Techlab, Inc. |
K181379 |
05/24/2018 |
H. PYLORI QUIK CHEK |
TECHLAB, Inc. |
K181400 |
05/29/2018 |
H. PYLORI CHEKÖ |
TECHLAB, Inc. |
K173217 |
10/03/2017 |
CAMPYLOBACTER QUIK CHEK |
Techlab, Inc. |
K173219 |
10/03/2017 |
CAMPYLOBACTER CHEK |
Techlab, Inc. |
K130401 |
02/19/2013 |
ALERTWATCH: OR |
ALERTWATCH LLC |
DEN180042 |
08/09/2018 |
Irregular Rhythm Notification Feature |
Apple Inc |
DEN180044 |
08/14/2018 |
ECG App |
Apple Inc |
K161372 |
05/17/2016 |
The Red Head Collection Device, The Jordy Connection System |
MIAMI FAT SUPPLY |
K983514 |
10/07/1998 |
POSITRON OPTION, MODEL NSCO-050A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
K230643 |
03/08/2023 |
CP620G LCD monitor, CP620 LCD monitor |
Nanjing Jusha Display Technology Co., Ltd |
K230723 |
03/16/2023 |
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
K230728 |
03/16/2023 |
JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd |
K231170 |
04/25/2023 |
C350/C350G LCD Monitor; M550/M550G LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
K212231 |
07/16/2021 |
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
K222121 |
07/18/2022 |
C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor |
Nanjing Jusha Display Technology Co., Ltd. |
K120729 |
03/09/2012 |
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 |
ETHICON ENDO-SURGERY, LLC |
K101990 |
07/15/2010 |
ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11 |
ETHICON ENDO-SUGERY, LLC |
K112033 |
07/15/2011 |
ENSEAL G2 TISSUS SEALERS |
ETHICON ENDO-SUGERY, LLC |
K123524 |
11/15/2012 |
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM |
MEDTRONIC NEUROSURGERY |
DEN120017 |
12/21/2012 |
Medtronic DUET External Drainage and Monitoring System |
MEDTRONIC NEUROSURGERY |
K203779 |
12/28/2020 |
Symmetric Total Knee System |
Signal Medical Corporation |
K090198 |
01/27/2009 |
JIAJIAN SELF-ADHESIVE ELECTRODE |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
K090199 |
01/27/2009 |
JIAJIAN ACUPUNCTURE NEEDLE |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
K130768 |
03/20/2013 |
JIAJIAN CMN STIMULATOR |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
K210954 |
03/30/2021 |
Synergy |
YRS Group Inc. |
K140865 |
04/03/2014 |
INFRARED HEATING DEVICE |
PRO MEDICAL SUPPLIES, INC. |
K150971 |
04/13/2015 |
Zekang Self-adhesive Electrode |
Jiangsu Zekang Medical Technology Co., Ltd |
K121718 |
06/11/2012 |
A-V FOOT PUMP |
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. |
K121719 |
06/11/2012 |
SM TENS & PMS |
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED |
K111907 |
07/05/2011 |
DYNAMIC DU SERIES PORTABLE DENTAL UNIT |
SHANGHAI DYNAMIC INDUSTRY CO., LTD. |
K181977 |
07/24/2018 |
WiScope Digital Endoscope System |
OTU Medical Inc. |
K112289 |
08/09/2011 |
DISPOSABLE THERMOMETER COVERS AND SHEATHS |
KANG ZE INDUSTRIAL CO. LIMITED |
K112288 |
08/09/2011 |
JIAJIAN TENS |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
K122812 |
09/13/2012 |
JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
K123830 |
12/12/2012 |
INTERMITTENT PNEUMATIC COMPRESSION DEVICE |
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. |
K123958 |
12/21/2012 |
JIAJIAN POINTOSELECT DIGITAL |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
K040440 |
02/20/2004 |
HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) |
HTTP HYPOTHERMIA THERAPY |
K200356 |
02/13/2020 |
MEDO ARIA |
Medo.ai |
K203502 |
11/30/2020 |
MEDO-Thyroid |
MEDO DX Pte. Ltd. |
K212709 |
08/26/2021 |
VoqX Electronic Stethoscope |
Sanolla Ltd. |
K191387 |
05/24/2019 |
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube |
Envizion Medical Ltd. |
K142483 |
09/04/2014 |
TurboSEAL Nasogastric Aspiration Tube |
TurboSEAL, L.P. |
K182915 |
10/18/2018 |
ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube |
ENvizion Medical Ltd. |
K203133 |
10/19/2020 |
ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube |
ENvizion Medical Ltd. |
K072960 |
10/19/2007 |
CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET |
CDP, LTD. |
K161406 |
05/20/2016 |
Navident |
ClaroNav Inc. |
K032585 |
08/21/2003 |
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM |
RON-TECH MEDICAL LTD. |
K955382 |
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