| K233926 |
12/13/2023 |
accufit |
Mettler Electronics Corporation |
| K223802 |
12/19/2022 |
accufit |
Mettler Electronics Corporation |
| K231915 |
06/29/2023 |
Zfx Abutments |
Zfx GmbH - a company of ZimVie |
| K243232 |
10/09/2024 |
GripMate |
Synthon Hispania S.L. |
| K222025 |
07/11/2022 |
G4Derm / G4Derm Plus Synthetic Wound Matrix |
Gel4Med, Inc. |
| K180437 |
02/20/2018 |
Hexanium« TLIF |
SpineVision, SAS |
| K193000 |
10/28/2019 |
Hexanium« ACIF |
SpineVision SAS |
| K022810 |
08/23/2002 |
COBRASCAN CR-1 FILMLESS |
RADIOGRAPHIC DIGITAL IMAGING, INC. |
| K090147 |
01/21/2009 |
BLOOD MONITORING UNIT, MODEL BMU 40 |
MAQUET CARDIOPULMONARY AG |
| K051619 |
06/17/2005 |
LIPOPROTEIN FOR MULTIPLE ANALYTES |
BAYER HEALTHCARE, LLC |
| K981171 |
04/01/1998 |
ERADIC-ALL |
THERATECHNOLOGIES, INC. |
| K150564 |
03/06/2015 |
Spaulding Electrocardiograph 2100iQ |
Spaulding Clinical Research, LLC |
| K202276 |
08/11/2020 |
BracePaste Band and Build LC |
American Orthodontics |
| K081670 |
06/13/2008 |
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK |
CARDINAL HEALTH 207, INC. |
| K081837 |
06/30/2008 |
AVEA VENTILATOR |
CARDINAL HEALTH 207, INC. |
| K173956 |
12/28/2017 |
Biowy PlCC Catheter |
Biowy Corporation |
| K171346 |
05/08/2017 |
Sapphire Sets |
ICU Medical |
| K051693 |
06/23/2005 |
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM |
BAYER HEALTHCARE, LLC |
| K240998 |
04/11/2024 |
ABL90 FLEX PLUS System |
Radiometer Medicals ApS |
| K241037 |
04/16/2024 |
ABL90 FLEX PLUS System |
Radiometer Medicals ApS |
| K080034 |
01/07/2008 |
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| K220593 |
03/01/2022 |
Spine Guidance Software, Stryker Q Guidance System |
Stryker Leibinger GmbH & Co. KG |
| K240662 |
03/08/2024 |
Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual T |
Stryker Leibinger GmbH & Co. KG |
| K172034 |
07/05/2017 |
Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap |
Stryker Corporation |
| K183196 |
11/19/2018 |
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker |
Stryker Corporation |
| K123209 |
10/12/2012 |
SOFTVUE |
DELPHINUS MEDICAL TECHNOLOGIES, INC |
| K142517 |
09/08/2014 |
SoftVue |
DELPHINUS MEDICAL TECHNOLOGIES, INC |
| K050374 |
02/14/2005 |
ADVIA IMS LITHIUM ASSAY |
BAYER HEALTHCARE, LLC |
| K050632 |
03/09/2005 |
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY |
BAYER HEALTHCARE, LLC |
| K030801 |
03/13/2003 |
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL |
BAYER HEALTHCARE, LLC |
| K030804 |
03/13/2003 |
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR |
BAYER HEALTHCARE, LLC |
| K061137 |
04/24/2006 |
ADVIA IMS CPSA CONTROL |
BAYER HEALTHCARE, LLC |
| K061139 |
04/24/2006 |
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS |
BAYER HEALTHCARE, LLC |
| K041133 |
04/30/2004 |
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER |
BAYER HEALTHCARE, LLC |
| K051265 |
05/16/2005 |
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY |
BAYER HEALTHCARE, LLC |
| K031644 |
05/27/2003 |
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL |
BAYER HEALTHCARE, LLC |
| K031857 |
06/16/2003 |
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY |
BAYER DIAGNOSTICS CORP. |
| K042015 |
07/27/2004 |
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE |
BAYER HEALTHCARE, DIAGNOSTICS DIVISION |
| K052163 |
08/09/2005 |
ADVIA IMS GLUCOSE ASSAY |
BAYER HEALTHCARE, LLC |
| K032525 |
08/15/2003 |
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER |
BAYER HEALTHCARE, LLC |
| K052242 |
08/17/2005 |
ADVIA CHEMISTRY MICROALBUMIN CONTROLS |
BAYER HEALTHCARE LLC |
| K042251 |
08/20/2004 |
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM |
BAYER HEALTHCARE, LLC |
| K052503 |
09/13/2005 |
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM |
BAYER HEALTHCARE, LLC |
| K042808 |
10/12/2004 |
ADVIA IMS CARBAMAZEPINE METHOD |
BAYER HEALTHCARE, LLC |
| K042807 |
10/12/2004 |
ADVIA IMS VALPROIC ACID METHOD |
BAYER HEALTHCARE, LLC |
| K033379 |
10/22/2003 |
BAYER SPECIAL CHEMISTRY CONTROLS |
BAYER DIAGNOSTICS CORP. |
| K033380 |
10/22/2003 |
BAYER SPECIAL CHEMISTRY CALIBRATORS |
BAYER DIAGNOSTICS CORP. |
| K053020 |
10/26/2005 |
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM |
BAYER HEALTHCARE, LLC |
| K023841 |
11/18/2002 |
AMMONIA ASSAY FOR THE ADVIA 1650 |
BAYER DIAGNOSTICS CORP. |
| K023840 |
11/18/2002 |
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 |
BAYER DIAGNOSTICS CORP. |
| K033791 |
12/04/2003 |
BAYER SPECIFIC PROTEIN REFERENCE SERUM |
BAYER HEALTHCARE, LLC |
| K230506 |
02/24/2023 |
PureLift Pro Edition |
Xtreem Pulse |
| K221443 |
05/18/2022 |
PureLift Pro Plus |
Xtreem Pulse LLC |
| K173483 |
11/13/2017 |
Pure Flow External Counter-Pulsation Device |
Xtreem Pulse, LLC |
| K243587 |
11/20/2024 |
PureLift GLOW |
Xtreem Pulse LLC |
| K190269 |
02/08/2019 |
PureLift |
Xtreem Pulse, LLC |
| K183012 |
10/31/2018 |
vascuCAP |
Elucid Bioimaging Inc. |
| K961118 |
03/20/1996 |
MAXIM PF MODELS 033-581/033-590 |
TELECTRONICS PACING SYSTEMS, INC. |
| K012512 |
08/06/2001 |
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM |
RADIANT MEDICAL |
| K042388 |
09/02/2004 |
RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE |
RADIANT MEDICAL |
| K024327 |
12/26/2002 |
SETPOINT ENDOVASCULAR TEMPERATURE PROBE |
RADIANT MEDICAL |
| K050644 |
03/14/2005 |
VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT |
VANCOUVER BIOTECH LTD. |
| K093444 |
11/05/2009 |
EXAPACS |
MEDINCOM TECHNOLOGY CORP |
| K040407 |
02/17/2004 |
QUICKELISA ANTHRAX-PA KIT |
IMMUNETICS, INC. |
| K010324 |
02/02/2001 |
STA-QUALITY HBPM/LMWH KIT |
DIAGNOSTICA STAGO, INC. |
| K010350 |
02/05/2001 |
STA -CALIBRATOR HBPM/LMWH KIT |
DIAGNOSTICA STAGO, INC. |
| K962675 |
07/09/1996 |
STA - LIATEST VWF TEST KIT |
AMERICAN BIOPRODUCTS CO. |
| K962674 |
07/09/1996 |
STA - VWF CONTROL [N]+[P] KIT |
AMERICAN BIOPRODUCTS CO. |
| K962671 |
07/09/1996 |
STA-VWF CALIBRATOR KIT |
AMERICAN BIOPRODUCTS CO. |
| K964728 |
11/25/1996 |
STA-LIATEST D-DI TEST KIT |
AMERICAN BIOPRODUCTS CO. |
| K964718 |
11/25/1996 |
STA D-DI CALIBRATOR KIT |
AMERICAN BIOPRODUCTS CO. |
| K964716 |
11/25/1996 |
STA LIATEST CONTROL [N]+[P] KIT |
AMERICAN BIOPRODUCTS CO. |
| K172080 |
07/10/2017 |
Photoelectric Therapy System |
Xstrahl Ltd. |
| K981858 |
05/27/1998 |
ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW |
ATLANTIS COMPONENTS, INC. |
| K101474 |
05/28/2010 |
MD VISION SYSTEM |
PERKINS HEALTHCARE TECHNOLOGIES |
| K954505 |
09/28/1995 |
EZ STIM |
LIFE-TECH INTL., INC. |
| K991062 |
03/31/1999 |
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 |
IMMUNETICS, INC. |
| K991063 |
03/31/1999 |
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 |
IMMUNETICS, INC. |
| K003754 |
12/05/2000 |
IMMUNETICS C6 LYME ELISA KIT |
IMMUNETICS, INC. |
| K163071 |
11/02/2016 |
vascuCAP |
Elucid Bioimaging, Inc. |
| K983460 |
09/30/1998 |
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER |
AMERICAN BIOPRODUCTS CO. |
| K010455 |
01/29/2001 |
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN |
DIAGNOSTICA-STAGO |
| K010963 |
03/30/2001 |
STA-LIATEST FREE PROTEIN S TEST KIT |
DIAGNOSTICA STAGO, INC. |
| K971519 |
04/25/1997 |
ASSERACHROM TPA TEST KIT |
AMERICAN BIOPRODUCTS CO. |
| K955040 |
11/03/1995 |
AT-III CONTROL PLASMA KIT |
AMERICAN BIOPRODUCTS CO. |
| K003767 |
12/06/2000 |
ASSERACHROM HPIA TEST KIT |
DIAGNOSTICA STAGO, INC. |
| K961579 |
04/24/1996 |
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER |
AMERICAN BIOPRODUCTS CO. |
| K210490 |
02/19/2021 |
ChM 4.5mm Cortical screws |
ChM sp. z o.o. |
| K210658 |
03/04/2021 |
Volition Plating System |
Ortho Solutions UK Ltd |
| K202764 |
09/21/2020 |
Ortho Solutions Plating System |
Ortho Solutions UK Ltd |
| K153416 |
11/25/2015 |
ArcScan Insight 100 |
ARCSCAN, INC. |
| K110503 |
02/22/2011 |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) |
AIRSTRIP TECHNOLOGIES, LP |
| K160862 |
03/29/2016 |
AirStrip RPM |
AirStrip Technologies, Inc. |
| K112235 |
08/04/2011 |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING |
AIRSTRIP TECHNOLOGIES, LP |
| K192372 |
08/30/2019 |
ASCEND Image Viewer |
Ascend Hit |
| K133554 |
11/19/2013 |
SURGICAL LIGHT HANDLE COVER |
MICROTEK MEDICAL, INC. AN ECOLAB COMPANY |
| K990527 |
02/19/1999 |
KLEENHANDS POWDERED LATEX EXAMINATION GLOVES |
SSN GLOVES (M) SDN BHD |
| K990526 |
02/19/1999 |
KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM |
SSN GLOVES (M) SDN BHD |
| K013773 |
11/13/2001 |
SAFE |
SSN MEDICAL PRODUCTS SDN. BHD. |
| K183432 |
12/11/2018 |
cobas u 601 urinalysis test system |
Roche Diagnostics |
| K190204 |
02/04/2019 |
ID NOW Influenza A & B 2 |
Alere Scarborough, Inc. |
| DEN180014 |
03/23/2018 |
WOUNDCHEK Bacterial Status |
Alere Scarborough, Inc. |
| K161364 |
05/17/2016 |
BinaxNOW G6PD Test |
ALERE SCARBOROUGH, INC. |
| K151464 |
06/01/2015 |
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit |
ALERE SCARBOROUGH, INC. |
| K141520 |
06/09/2014 |
ALERE I INFLUENZA A & B |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
| K191534 |
06/10/2019 |
ID NOW Influenza A & B 2 |
Abbott Diagnostics Scarborough, Inc. |
| K171792 |
06/16/2017 |
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit |
Alere Scarborough, Inc. |
| K151690 |
06/23/2015 |
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A |
ALERE SCARBOROUGH, INC. |
| K121905 |
06/29/2012 |
ALERE PBP2A TEST |
ALERE SCARBOROUGH, INC |
| K141757 |
06/30/2014 |
ALERE I STREP A |
ALERE SCARBOROUGH, INC |
| K181853 |
07/11/2018 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader |
Alere Scarborough, Inc. |
| K092223 |
07/23/2009 |
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
| K062109 |
07/24/2006 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
| K053126 |
11/07/2005 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
| K133637 |
11/07/2013 |
ALERE INFLUENZA A & B TEST |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
| K133411 |
11/07/2013 |
ALERE BINAXNOW INFLUENZA A & B CARD |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
| K163266 |
11/21/2016 |
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument |
ALERE SCARBOROUGH, INC. |
| K123986 |
12/26/2012 |
ACTIM PROM |
ALERE SCARBOROUGH, INC |
| K173932 |
12/26/2017 |
Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 |
Alere Scarborough, Inc. |
| K964825 |
12/02/1996 |
FREEDOM TRAVELLER |
IMPACT CASE TECHNOLOGIES, INC. |
| K040119 |
01/20/2004 |
PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION |
SYNOVIS SURGICAL INNOVATIONS |
| K040415 |
02/18/2004 |
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT |
SYNOVIS SURGICAL INNOVATIONS |
| K220759 |
03/15/2022 |
Armis VeriCyn Wound Wash |
Armis Biopharma, Inc. |
| K230743 |
03/16/2023 |
ICHOR 14F Embolectomy System |
ICHOR |
| K030879 |
03/20/2003 |
VERITAS COLLAGEN MATRIX |
SYNOVIS SURGICAL INNOVATIONS |
| K991194 |
04/08/1999 |
MODIFICATION TO ULTRA-SELECT GUIDEWIRE |
MICROVENA CORP. |
| K191275 |
05/13/2019 |
AllÆInCath 035M PTA Balloon Dilatation Catheter |
NexStep Medical |
| K991898 |
06/04/1999 |
ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE |
MICROVENA CORP. |
| K201631 |
06/16/2020 |
VersaWrap Nerve Protector |
Alafair Biosciences Inc |
| K232029 |
07/07/2023 |
VersaWrap Nerve Protector |
Alafair Biosciences Inc |
| K213173 |
09/28/2021 |
TrabEx Pro |
MicroSurgical Technologies Inc |
| K213163 |
09/28/2021 |
VersaWrap |
Alafair Biosciences Inc |
| K203600 |
12/09/2020 |
VersaWrap |
Alafair Biosciences Inc |
| K100548 |
02/26/2010 |
VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP |
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
| K142618 |
09/16/2014 |
Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System |
Hitachi Aloka Medical America, Inc. |
| K162902 |
10/17/2016 |
ARIETTA Prologue Diagnostic Ultrasound system and Transducers |
HITACHI, LTD. |
| K093372 |
10/29/2009 |
SILS PORT MODEL SILSPT15 |
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
| K153421 |
11/25/2015 |
HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS |
HITACHI ALOKA MEDICAL AMERICA, INC. |
| K123828 |
12/12/2012 |
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM |
HITACHI ALOKA MEDICAL, LTD. |
| K130308 |
02/07/2013 |
NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM |
HITACHI ALOKA MEDICAL, LTD. |
| K140443 |
02/21/2014 |
ARIETTA 60/ARIETTAS60/ARIETTAV60 |
HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL |
| K140639 |
03/12/2014 |
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM |
HITACHI ALOKA MEDICAL, LTD. |
| K140854 |
04/03/2014 |
INTRA-OPERATIVE ULTRASOUND TRANSDUCER |
HITACHI ALOKA MEDICAL, LTD. |
| K134016 |
12/30/2013 |
ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL |
| K151025 |
04/16/2015 |
iHearTest |
IHEAR MEDICAL, INC. |
| K230276 |
02/01/2023 |
TECHFIT DISRP« System |
TECHFIT Digital Surgery |
| K112349 |
08/16/2011 |
VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
| K121194 |
04/19/2012 |
ENDO CLIP III 5MM CLIP APPLIER |
COVIDIEN |
| K160559 |
02/29/2016 |
NOBLUSÖ Ultrasound Diagnostic System |
HITACHI MEDICAL CORPORATION |
| K152126 |
07/31/2015 |
UST-5550-R; UST-5536-R; L43K |
HITACHI ALOKA MEDICAL AMERICA, INC. |
| K142368 |
08/25/2014 |
NOBLUS DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI ALOKA MEDICAL, LTD. |
| K162583 |
09/15/2016 |
ALOKA LISENDO 880 |
HITACHI, LTD. |
| K163505 |
12/14/2016 |
ARIETTA PRECISION |
HITACHI, LTD |
| K024079 |
12/10/2002 |
ALIBI BIOLOGICAL INDICATOR, MODEL WS |
ARDEN LABORATORIES, INCORPORATED |
| K971561 |
04/29/1997 |
PROVEST-PROTECTIVE RESTRAINT |
JEMM MEDICAL PRODUCTS |
| K180693 |
03/16/2018 |
CoaguChek XS Pro System |
Roche Diagnostics |
| K033158 |
09/30/2003 |
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES |
SYNTHES (USA) |
| K193008 |
10/28/2019 |
Tricoglam Home Use |
Advihair S.R.L. |
| K980994 |
03/17/1998 |
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES |
VENETEC INTL., INC. |
| K213727 |
11/26/2021 |
dS Sentinelle Breast 16ch 3.0T Coil |
Invivo Corporation (Business Trade Name: Philips) |
| K213735 |
11/29/2021 |
dS Sentinelle Breast 16ch 1.5T Coil |
Invivo Corporation (Business Trade Name: Philips) |
| K213766 |
12/01/2021 |
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T |
Invivo Corporation |
| K070657 |
03/09/2007 |
GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER |
GETINGE SOURCING LLC |
| K120004 |
01/03/2012 |
(MULTIPLE) DIGITAL THERMOMETER |
CHINA SHENYANG MED-LAND IMP/EXP CORP., LTD. |
| K011679 |
05/30/2001 |
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY |
EMBRYOTECH LABORATORIES, INC. |
| K983473 |
10/02/1998 |
FERTILMARQ TEST KIT |
EMBRYOTECH LABORATORIES, INC. |
| K003415 |
11/02/2000 |
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE |
WANG & LI, INC. |
| K050103 |
01/18/2005 |
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM |
ABBOTT LABORATORIES |
| K050501 |
02/28/2005 |
MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM |
ABBOTT VASCULAR DEVICES |
| K051519 |
06/08/2005 |
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) |
ABBOTT LABORATORIES (PERCLOSE, INC.) |
| K173335 |
10/23/2017 |
Gazelle PTFE and Suture Delivery Device |
Dura Tap LLC |
| K173644 |
11/27/2017 |
Gazelle Polypropylene Suture and Delivery Device |
Dura Tap LLC |
| K970460 |
02/06/1997 |
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) |
PURITAN BENNETT CORP. |
| K964540 |
11/12/1996 |
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM |
PURITAN BENNETT CORP. |
| K984535 |
12/21/1998 |
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION |
PURITAN BENNETT CORP. |
| K210386 |
02/09/2021 |
Magneto Nasal Mask |
Respironics, Inc. |
| K240534 |
02/26/2024 |
Bio-Medicus Life Support Catheter and Introducer |
Medtronic Inc. |
| K240880 |
04/01/2024 |
VitalFlow Set with Balance Biosurface |
Medtronic Inc. |
| K223168 |
10/11/2022 |
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with BalanceÖ Biosurface |
Medtronic Inc. |
| K040580 |
03/04/2004 |
AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR |
D.Y. INSTRUMENT, INC. |
| K990516 |
02/18/1999 |
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS |
EMD CHEMICALS INC. |
| K031367 |
04/30/2003 |
DUOPATH VEROTOXINS GLISA TEST |
EMD CHEMICALS INC. |
| K981926 |
06/02/1998 |
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS |
EMD CHEMICALS INC. |
| K973054 |
08/15/1997 |
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS |
EMD CHEMICALS INC. |
| K241790 |
06/21/2024 |
XCELLARISPRO TWIST microneedling device |
Dermaroller GmbH |
| K083463 |
11/24/2008 |
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K093645 |
11/25/2009 |
EXL ANEM CAL, MODEL RC640 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K150168 |
01/26/2015 |
Dimension Tacrolimus Flex« Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K081249 |
05/02/2008 |
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM |
DADE BEHRING, INC. |
| K082503 |
08/29/2008 |
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K093631 |
11/24/2009 |
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K023629 |
10/28/2002 |
ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 |
GUIDANT CORPORATION, CARDIAC SURGERY |
| K061221 |
05/02/2006 |
DUPUY S-ROM STD HIP STEM PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
| K061833 |
06/29/2006 |
DEPUY AML HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
| K060581 |
03/07/2006 |
DEPUY SOLUTION SYSTEM HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
| K062148 |
07/27/2006 |
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER |
DEPUY ORTHOPAEDICS, INC. |
| K062426 |
08/18/2006 |
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
| K062748 |
09/14/2006 |
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD |
DEPUY ORTHOPAEDICS, INC. |
| K173536 |
11/15/2017 |
T2Candida 1.1 Panel |
T2 Biosystems, Inc. |
| K191424 |
05/29/2019 |
Interphalangeal Joint Fusion Device Range |
Neosteo |
| K192447 |
09/06/2019 |
Superelastic Staple |
Neosteo |
| K171905 |
06/26/2017 |
VISCO 360 Viscosurgical System |
Sight Sciences, Inc. |
| K173332 |
10/23/2017 |
OMNI Surgical System |
Sight Sciences, Inc. |
| K203727 |
12/21/2020 |
Harmony Latex Dam, Harmony Non-Latex Dam |
Pamco Distributing Inc. |
| K982860 |
08/13/1998 |
UM-L20/ UM-L30 |
UNION MEDICAL ENGENEERING CO., LTD. |
| K000222 |
01/24/2000 |
UM-L25 |
UNION MEDICAL ENGENEERING CO., LTD. |
| K981310 |
04/10/1998 |
MAGNATEK C-300 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K981430 |
04/20/1998 |
UNION MEDICAL UM-D30 COAGULATOR |
SHE MEDICAL, INC. |
| K981416 |
04/20/1998 |
MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K991819 |
05/27/1999 |
MAGNATEK 30 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K981908 |
06/01/1998 |
UM-150A |
UMECO UNION MEDICAL ENGINEERING |
| K012071 |
07/02/2001 |
ENT LASERVISION |
UNION MEDICAL USA |
| K982405 |
07/10/1998 |
MTEK-1000 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K982846 |
08/12/1998 |
MTEK-1400 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K982907 |
08/18/1998 |
MAGNATEK 40 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K983114 |
09/04/1998 |
MAGNATEK80 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
| K963985 |
10/04/1996 |
UM-D3000/UM-D4000 |
J.J. CONSULTING SERVICES, INC. |
| K040640 |
03/10/2004 |
MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL |
IGC-MEDICAL ADVANCES, INC. |
| K041185 |
05/06/2004 |
TORSO ARRAY COIL, MODEL 558GE-64 |
IGC-MEDICAL ADVANCES, INC. |
| K023084 |
09/17/2002 |
MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL |
MEDICAL ADVANCES, INC. |
| K033292 |
10/14/2003 |
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 |
IGC-MEDICAL ADVANCES, INC. |
| K971164 |
03/31/1997 |
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS |
ASPECT VISION CARE, LTD. |
| K082286 |
08/11/2008 |
BIOACTYS |
GRAFTYS |
| K082498 |
08/29/2008 |
GRAFTYS HBS |
GRAFTYS |
| K093343 |
10/26/2009 |
GRAFTY QUICKSET |
GRAFTYS |
| K073064 |
10/30/2007 |
GRAFTYS BCP |
GRAFTYS |
| K963648 |
09/12/1996 |
STRYKER SUCTION REGULATOR |
Stryker Endoscopy |
| K963646 |
09/12/1996 |
STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW |
Stryker Endoscopy |
| K063456 |
11/15/2006 |
SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM |
TOPEX, INC |
| K140439 |
02/21/2014 |
OMNIPOD INSULIN MANAGEMENT SYSTEM |
INSULET CORPORATION |
| K170473 |
02/16/2017 |
C2 femoral stem |
Limacorporate S.p.A. |
| K970168 |
01/16/1997 |
3M QUIKPLUS SYSTEM |
3M COMPANY |
