| K210122 |
01/19/2021 |
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) |
Osteonic Co., Ltd. |
| K231322 |
05/08/2023 |
Fix2Lock(PEEK Self Punching) |
Osteonic Co., Ltd. |
| K231326 |
05/08/2023 |
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) |
Osteonic Co., Ltd. |
| K202763 |
09/21/2020 |
Fix2Lock (PEEK Self Punching) |
Osteonic Co., Ltd. |
| K202806 |
09/23/2020 |
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) |
OSTEONIC Co., Ltd. |
| K180232 |
01/29/2018 |
DAEHAN Disposable CUP Electrodes |
Daehan Medical Systems Co., Ltd. |
| K212516 |
08/10/2021 |
IRNF App |
Apple Inc. |
| K053354 |
12/02/2005 |
INTERMEZZO PLUS FIXTURE |
MEGAGEN CO., LTD. |
| K053353 |
12/02/2005 |
RESCUE IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
| K052369 |
08/29/2005 |
EXFEEL IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
| K042339 |
08/30/2004 |
NEOPLANT IMPLANT SYSTEM |
NEOBIOTECH CO., LTD. |
| K070562 |
02/27/2007 |
EZ PLUS IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
| K050635 |
03/31/2005 |
ALLFIM IMPLANT SYSTEMS |
COWELL MEDI CO LTD. |
| K051018 |
04/21/2005 |
INTERMEZZO IMPLANT SYSTEMS |
MEGAGEN CO., LTD. |
| K041378 |
05/24/2004 |
BIO 60 |
KODENT, INC. |
| K041655 |
06/18/2004 |
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) |
COWELL MEDI CO LTD. |
| K061797 |
06/26/2006 |
SM IMPLANT SYSTEMS |
DIO DEPARTMENT DSI, INC. |
| K031010 |
03/31/2003 |
MIRACLE 98 |
SB LUCIUS, INC. |
| K021947 |
06/13/2002 |
CERANUM 87 |
LUCIUS METALS COM. |
| K021948 |
06/13/2002 |
LUCIUS 62 |
LUCIUS METALS COM. |
| K023200 |
09/25/2002 |
CERANUM 76 |
SB LUCIUS, INC. |
| K023196 |
09/25/2002 |
LUCIUS 76 |
SB LUCIUS, INC. |
| K023197 |
09/25/2002 |
CERANUM 82 |
SB LUCIUS, INC. |
| K023198 |
09/25/2002 |
CERANUM 90 |
SB LUCIUS, INC. |
| K023199 |
09/25/2002 |
CERANUM 50 |
SB LUCIUS, INC. |
| K024144 |
12/16/2002 |
AIGIS-PT |
SB LUCIUS, INC. |
| K024135 |
12/16/2002 |
AIGIS-PLUS |
SB LUCIUS, INC. |
| K024139 |
12/16/2002 |
AIGIS-INLAY |
SB LUCIUS, INC. |
| K024140 |
12/16/2002 |
AIGIS-A |
SB LUCIUS, INC. |
| K024141 |
12/16/2002 |
NEO 76 |
SB LUCIUS, INC. |
| K024145 |
12/16/2002 |
AIGIS-XO |
SB LUCIUS, INC. |
| K024143 |
12/16/2002 |
AIGIS-FINE |
SB LUCIUS, INC. |
| K024142 |
12/16/2002 |
AIGIS-SUPER |
SB LUCIUS, INC. |
| K024136 |
12/16/2002 |
AIGIS-SOFT |
SB LUCIUS, INC. |
| K071134 |
04/23/2007 |
SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM |
SONOSITE,INC. |
| K092058 |
07/08/2009 |
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM |
SONOSITE,INC. |
| K052109 |
08/04/2005 |
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) |
SONOSITE,INC. |
| K053069 |
11/01/2005 |
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) |
SONOSITE,INC. |
| K043452 |
12/15/2004 |
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM |
SONOSITE,INC. |
| K043559 |
12/27/2004 |
SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) |
SONOSITE,INC. |
| K202663 |
09/14/2020 |
Suture Wing |
Osteonic Co., Ltd. |
| K210422 |
02/11/2021 |
INTAI Surgical Mask (non-sterile) |
INTAI Technology Corp. |
| K201229 |
05/07/2020 |
Intai Anatomic Locking Plate and Screw System |
Intai Technology Corporation |
| K200659 |
03/12/2020 |
Dermalux Tri-Wave MD |
Aesthetic Technology Ltd. |
| K212275 |
07/20/2021 |
Dermalux Flex MD |
Aesthetic Technology Ltd. |
| K202028 |
07/22/2020 |
dermalux Flex MD |
Aesthetic Technology Ltd |
| K001688 |
06/02/2000 |
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER |
DATEX-OHMEDA, INC. |
| K993512 |
10/18/1999 |
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER |
DATEX-OHMEDA, INC. |
| K120280 |
01/30/2012 |
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM |
ACCLARENT, INC. |
| K113831 |
12/27/2011 |
PRIMUS HEARING INSTRUMENT TEST UNIT |
AUDITDATA A/S |
| K160578 |
03/01/2016 |
Nustat XR |
Beeken Biomedical, LLC |
| K250677 |
03/06/2025 |
LEGION Total Knee System |
Smith & Nephew, Inc. |
| K242375 |
08/09/2024 |
OR3O Dual Mobility System |
Smith & Nephew, Inc. |
| K202275 |
08/11/2020 |
CorPath GRX System |
Corindus, Inc. |
| K231396 |
05/15/2023 |
CEPHX- Cephalometric Analysis Software |
Orca Dental AI LTD |
| K244027 |
12/30/2024 |
SANSA HSAT |
Huxley Medical |
| 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. |
| K001429 |
05/05/2000 |
MODIFICATION TO ACCUDEXA BONE DENSITOMETER |
SCHICK TECHNOLOGIES, INC. |
| K041385 |
05/25/2004 |
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM |
SCHICK TECHNOLOGIES, INC. |
| K022953 |
09/05/2002 |
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM |
SCHICK TECHNOLOGIES, INC. |
| K193130 |
11/12/2019 |
MVP Aligner System |
MVP Aligners, LLC |
| K053558 |
12/21/2005 |
CEPH, MODEL 4900 |
SCHICK TECHNOLOGIES, INC. |
| K170372 |
02/07/2017 |
SpiralTech Dental Implant System |
SpiralTech Superior Dental Implants, Inc. |
| K191267 |
05/10/2019 |
ImagingRing System on Rails |
MedPhoton GmbH |
| K161400 |
05/20/2016 |
ImagingRing System |
MEDPHOTON GMBH |
| K203281 |
11/06/2020 |
Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X |
medPhoton GmbH |
| K211807 |
06/11/2021 |
Sapphire NC 24 |
OrbusNeich Medical (Shenzhen) Co., Ltd. |
| K201794 |
06/30/2020 |
Jade |
OrbusNeich Medical (Shenzhen) Co., Ltd. |
| K202231 |
08/07/2020 |
JADE |
OrbusNeich Medical (Shenzhen) Co., Ltd. |
| K143185 |
11/05/2014 |
entrΘ Model PD08-U |
TACTILE SYSTEMS TECHNOLOGY INC |
| K050620 |
03/10/2005 |
READMYHEART, MODEL RMH3.0 |
DAILYCARE BIOMEDICAL INC |
| K062894 |
09/27/2006 |
INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 |
DAILYCARE BIOMEDICAL INC |
| K960834 |
02/29/1996 |
KODAK EC-L CASSETTE |
EASTMAN KODAK COMPANY |
| K020566 |
02/20/2002 |
FUJIREBIO DIAGNOSTICS CA 19-9 RIA |
FUJIREBIO DIAGNOSTICS, INC. |
| K022891 |
08/30/2002 |
THE BREATHE EZ ANTI-SNORING DEVICE |
D&S REDHAGE |
| K052303 |
08/24/2005 |
READMYHEART, MODEL RMH2.0 |
DAILYCARE BIOMEDICAL INC |
| K200956 |
04/09/2020 |
NuVasive Thoracolumbar Plates |
NuVasive, Incorporated |
| K201820 |
07/01/2020 |
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody |
NuVasive, Incorporated |
| K222240 |
07/26/2022 |
EXPLORER AIR« II |
SurgVision GmbH |
| K234090 |
12/22/2023 |
EXPLORER AIR« II (8001, 8002, 8003); EXPLORER AIR« Sterile Drape (8004) |
SurgVision GmbH |
| K214097 |
12/28/2021 |
Explorer Air II |
SurgVision GmbH |
| K230476 |
02/22/2023 |
Oran Park Mask |
ResMed Pty Ltd (Registration Number: 3004604967) |
| K112797 |
09/26/2011 |
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER |
CORDIS CORP. |
| K230722 |
03/16/2023 |
Eagle device |
BELKIN Vision Ltd. |
| K163070 |
11/02/2016 |
Kent Camera |
KENT IMAGING INC. |
| K113507 |
11/28/2011 |
KENT CAMERA |
KENT IMAGING INC. |
| K232607 |
08/28/2023 |
4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM |
Solco Biomedical Copany India Private Limited |
| K213653 |
11/19/2021 |
4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM |
Solco Biomedical Company India Private Limited |
| K001879 |
06/20/2000 |
INFUSION IV SET |
NIRVI INTL. USA |
| 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. |
| K131193 |
04/26/2013 |
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM |
TACTILE SYSTEMS TECHNOLOGY INC |
| K173233 |
10/05/2017 |
ReliefBand 1.5 |
ReliefBand Technologies |
| K133788 |
12/12/2013 |
COOK HOLMIUM LASER FIBER |
COOK INCORPORATED |
| K052732 |
09/29/2005 |
ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P |
ABRACAIR, INC. |
| K222416 |
08/10/2022 |
RIA Safeguard |
RIA Tech Co., Ltd. |
| K171781 |
06/15/2017 |
eVox System |
Evoke Neuroscience, Inc. |
| K980187 |
01/20/1998 |
MLT R694 RUBY LASER SYSTEM |
MEDICAL LASER TECHNOLOGIES LTD. |
| K990902 |
03/18/1999 |
MODIFICATION OF MLT R694 RUBY LASER SYSTEM |
MEDICAL LASER TECHNOLOGIES LTD. |
| K970521 |
02/11/1997 |
TRX POWER TILT AND RECLINE SYSTEM |
MOTION CONCEPTS |
| K981837 |
05/26/1998 |
TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS |
MOTION CONCEPTS |
| K040592 |
03/08/2004 |
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE |
CORDIS CORP. |
| K180885 |
04/04/2018 |
HairMax Laser |
Lexington International, LLC |
| K112524 |
08/31/2011 |
HAIRMAX LASERCOMB |
LEXINGTON INTERNATIONAL, LLC |
| K142573 |
09/12/2014 |
HairMax LaserComb, HairMax LaserComb |
LEXINGTON INTERNATIONAL, LLC |
| K121108 |
04/12/2012 |
DOPPLEX ABILITY |
HUNTLEIGH HEALTHCARE |
| K091591 |
06/02/2009 |
FLEXICARE MEDICAL ENDOTRACHEAL TUBES |
FLEXICARE MEDICAL LTD. |
| K092218 |
07/22/2009 |
FLEXICARE BREATHING FILTERS |
FLEXICARE MEDICAL LTD. |
| K122330 |
08/02/2012 |
FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE |
ARJOHUNTLEIGH POLSKA SP Z.O.O. |
| K133119 |
09/30/2013 |
FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS |
ARJOHUNTLEIGH POLSKA SP Z.O.O. |
| K000808 |
03/13/2000 |
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE |
RICH-MAR CORP. |
| K040679 |
03/15/2004 |
RICH-MAR AUTOPRISM INFRARED LAMP |
RICH-MAR CORP. |
| K031018 |
03/31/2003 |
AUTOGEL PAD |
RICH-MAR CORP. |
| K021483 |
05/08/2002 |
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND |
RICH-MAR CORP. |
| K982544 |
07/21/1998 |
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES |
RICH-MAR CORP. |
| K012848 |
08/23/2001 |
WINNER CM4 COMBINATION UNIT |
RICH-MAR CORP. |
| K032941 |
09/22/2003 |
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE |
RICH-MAR CORP. |
| K013770 |
11/13/2001 |
MODIFICATION TO: WINNER ST-2 STIMULATOR |
RICH-MAR CORP. |
| K013771 |
11/13/2001 |
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE |
RICH-MAR CORP. |
| K070825 |
03/26/2007 |
LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR |
LITTLE DOCTOR (SHANGHAI) ELECTRONIC MANUFACTURING |
| K141595 |
06/13/2014 |
O-TWO E700,O-TWO E600,O-TWO E500 |
O-TWO MEDICAL TECHNOLOGIES, INC. |
| K092245 |
07/28/2009 |
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 |
HONSUN (NANTONG) CO., LTD |
| K173205 |
10/02/2017 |
Equinox Advantage |
O-Two Medical Technologies Inc. |
| K113687 |
12/15/2011 |
EQUINOX RELIEVE |
O-TWO MEDICAL TECHNOLOGIES, INC. |
| K093862 |
12/17/2009 |
CAREVENT HANDHELD CPAP SYSTEM |
O-TWO MEDICAL TECHNOLOGIES, INC. |
| K982076 |
06/12/1998 |
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM |
AMIRA MEDICAL, INC. |
| K130293 |
02/06/2013 |
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
COOK, INC. |
| K041633 |
06/16/2004 |
GYRUS PLASMACISION LAPAROSCOPIC SPATULA |
GYRUS MEDICAL, INC. |
| K023471 |
10/15/2002 |
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP |
DISETRONIC MEDICAL SYSTEMS AG |
| K013782 |
11/14/2001 |
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE |
DISETRONIC MEDICAL SYSTEMS |
| K003977 |
12/22/2000 |
DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET |
DISETRONIC MEDICAL SYSTEMS AG |
| K133130 |
09/30/2013 |
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER |
COOK, INC. |
| K173289 |
10/16/2017 |
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter |
Cook Incorporated |
| K103740 |
12/22/2010 |
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE |
SPECTRA MEDICAL DEVICES, INC. |
| K123217 |
10/15/2012 |
CARDEASCREEN |
CARDEA ASSOCIATES INC |
| K030290 |
01/23/2003 |
PERIOLASE ND:YAG DENTAL LASER SYSTEM |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
| K010771 |
03/14/2001 |
PERIOLASE ND:YAG DENTAL LASER SYSTEM |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
| K151763 |
06/29/2015 |
PerioLase Nd:YAG Pulsed Dental Laser System |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
| K014272 |
12/27/2001 |
PERIOLASE ND:YAG DENTAL LASER SYSTEM |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
| K102134 |
07/29/2010 |
MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM |
UNITED INTEGRATED SERVICES CO., LTD. |
| K082686 |
09/15/2008 |
MULTI-CHANNEL LASER THERAPY SYSTEM |
UNITED INTEGRATED SERVICES CO., LTD. |
| K981923 |
06/01/1998 |
THE SNORE PEACE |
THE SNORE PEACE GROUP |
| K120431 |
02/13/2012 |
HALO90 ULTRA ABLATION CATHETER |
BARRX MEDICAL, INC. |
| K140553 |
03/04/2014 |
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS |
INTUITIVE SURGICAL, INC. |
| K172510 |
08/21/2017 |
╡Cor Heart Failure and Arrhythmia Management System |
ZOLL Manufacturing Corporation |
| K112454 |
08/25/2011 |
HALO60 ABLATION CATHETER |
BARRX MEDICAL, INC. |
| K083287 |
11/07/2008 |
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM |
CORVENTIS, INC. |
| K242297 |
08/02/2024 |
Reform Pedicle Screw System |
Precision Spine, Inc. |
| K180356 |
02/08/2018 |
inui In-Home Urine Analysis Test System |
Scanadu, Inc. |
