| K172252 |
07/26/2017 |
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern |
Euroimmun US, Inc. |
| K172244 |
07/26/2017 |
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern |
Euroimmun US, Inc. |
| K183313 |
11/29/2018 |
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) |
Euroimmun US, Inc. |
| K083641 |
12/09/2008 |
BIVONA TRACHEOSTOMY TUBES |
SMITHS MEDICAL ASD, INC. |
| 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 |
| K221984 |
07/06/2022 |
InterView XP; InterView FUSION |
Mediso Medical Imaging Systems, LTtd. |
| K090256 |
02/02/2009 |
POWER STANDING DANI |
DAVISMADE, INC. |
| K181306 |
05/17/2018 |
Actifuse Flow |
Baxter Healthcare Corporation |
| K162723 |
09/29/2016 |
TransFix/EDTA Vacuum Blood Collection Tubes |
Caltag Medsystems Ltd. |
| K201494 |
06/05/2020 |
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card |
Advin Biotech, Inc. |
| K982115 |
06/16/1998 |
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY |
RIM-WIDE COMPANIES, INC. |
| DEN000001 |
01/07/2000 |
OHMEDA INOVENT DELIVERY SYSTEM |
OHMEDA MEDICAL |
| K990132 |
01/14/1999 |
DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC |
DATEX-OHMEDA, INC. |
| K000186 |
01/14/2000 |
DATEX-OHMEDA INOVENT DELIVERY SYSTEM |
DATEX-OHMEDA |
| K000275 |
01/31/2000 |
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA |
DATEX-OHMEDA, INC. |
| K000706 |
03/02/2000 |
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR |
DATEX-OHMEDA, INC. |
| K100744 |
03/16/2010 |
CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 |
NEUWAVE MEDICAL, INC |
| K002878 |
09/15/2000 |
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER |
DATEX-OHMEDA, INC. |
| K993410 |
10/12/1999 |
DATES-OHMEDA AESTIVA SMARTVENT MRI |
DATEX-OHMEDA, INC. |
| DEN220087 |
12/02/2022 |
Edison System |
HistoSonics, Inc. |
| K160194 |
01/27/2016 |
StarFuse Interphalangeal Pin |
Phalanx Innovations |
| K160304 |
02/04/2016 |
OsteoBullet Compression Screw |
Phalanx Innovations |
| K152255 |
08/10/2015 |
BoneCam Suture Anchors |
VALERIS MEDICAL |
| K142230 |
08/13/2014 |
Apollo Suture Anchor System and Titan Screws |
Valeris Medical |
| K213232 |
09/30/2021 |
NovaCore Semi-Automatic Biopsy Instrument |
Argon Medical Devices |
| K173775 |
12/12/2017 |
Clench Compression Staple |
F & A Foundation LLC d.b.a. Reign Medical |
| K970657 |
02/21/1997 |
LMI THROMBECTOMY CATHETER |
LUCAS MEDICAL, INC. |
| K972623 |
07/14/1997 |
LMI IRRIGATION CATHETER (IGR) |
LUCAS MEDICAL, INC. |
| K954760 |
10/17/1995 |
LMI ARTERIAL EMBOLECTOMY CATHETER |
LUCAS MEDICAL, INC. |
| K983802 |
10/28/1998 |
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB |
LUCAS MEDICAL, INC. |
| K982031 |
06/10/1998 |
OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE |
IRIDEX CORP. |
| K041199 |
05/07/2004 |
MEDI-PUMP ASPIRATOR, MODEL 1615 |
THOMAS INDUSTRIES |
| K153156 |
11/02/2015 |
eCareManager 4.0.1 |
VISICU, INC. |
| K170372 |
02/07/2017 |
SpiralTech Dental Implant System |
SpiralTech Superior Dental Implants, Inc. |
| K152202 |
08/06/2015 |
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm |
TNI Manufacturing, Inc. |
| K152876 |
09/30/2015 |
LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM |
TNI Manufacturing, Inc. |
| K081234 |
05/01/2008 |
GN OTOMETRICS INSERT EARPHONES |
GN OTOMETRICS |
| 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 |
| K181498 |
06/07/2018 |
X-ray Imaging System for the McLaren Proton Treatment System |
EhmetDx, LLC |
| K160244 |
02/01/2016 |
VARIOunite |
Thommen Medical AG |
| K171795 |
06/16/2017 |
Thommen Implant System |
Thommen Medical AG |
| K151984 |
07/17/2015 |
Thommen Milling Abutment for CAD/CAM |
THOMMEN MEDICAL AG |
| K100356 |
02/12/2010 |
TDS PRECISION DENTAL BAR |
POU YU BIOTECHNOLOGY CO., LTD. |
| K112621 |
09/08/2011 |
WIS1000 |
FORESEESON CUSTOM DISPLAYS, INC. |
| K091026 |
04/10/2009 |
TDS ABUTMENT FOR NOBEL BIOCARE REPLACE |
POU YU BIOTECHNOLOGY CO., LTD. |
| K091392 |
05/11/2009 |
TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK |
POU YU BIOTECHNOLOGY CO., LTD. |
| K091693 |
06/10/2009 |
TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK |
POU YU BIOTECHNOLOGY CO., LTD. |
| K103339 |
11/15/2010 |
TDS ABUTMENT FOR FRIADENT XIVE |
POU YU BIOTECHNOLOGY CO., LTD. |
| K043531 |
12/21/2004 |
MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 |
K-JUMP HEALTH CO., LTD. |
| K180124 |
01/16/2018 |
ZQuiet |
Sleeping Well,LLC |
| K122475 |
08/14/2012 |
ZQUIET PRO-PLUS |
SLEEPING WELL, LLC |
| K213088 |
09/24/2021 |
ZQuiet Advance |
Sleeping Well, LLC |
| K202092 |
07/28/2020 |
ABC Dental Implant System |
Abracadabra Implants Ltd |
| K210457 |
02/16/2021 |
7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key |
7D Surgical Inc. |
| K210555 |
02/25/2021 |
7D Surgical System - Drill Guide |
7D Surgical Inc. |
| K201966 |
07/15/2020 |
7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array |
7D Surgical Inc. |
| K192945 |
10/18/2019 |
7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application |
7D Surgical Inc. |
| K180352 |
02/08/2018 |
7D Surgical System |
7D Surgical Inc. |
| K220522 |
02/23/2022 |
7D Surgical System - Percutaneous Application (7D Flash Frame) |
7D Surgical |
| K181041 |
04/19/2018 |
7D Surgical System Cranial Application |
7D Surgical Inc. |
| K192140 |
08/08/2019 |
7D Surgical System |
7D Surgical Inc. |
| K162375 |
08/24/2016 |
Envision 3D: Image Guidance System |
7D SURGICAL INC. |
| K183276 |
11/23/2018 |
7D Surgical System |
7D Surgical Inc. |
| K012749 |
08/16/2001 |
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 |
BIOCARDIA, INC. |
| K042553 |
09/20/2004 |
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER |
BIOCARDIA, INC. |
| K072032 |
07/24/2007 |
IGG ANTI-ATHEROX TEST KIT |
CORGENIX, INC. |
| K143185 |
11/05/2014 |
entrΘ Model PD08-U |
TACTILE SYSTEMS TECHNOLOGY 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. |
| K960834 |
02/29/1996 |
KODAK EC-L CASSETTE |
EASTMAN KODAK COMPANY |
| K071230 |
05/03/2007 |
APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 |
ADVANCED BRAIN MONITORING, INC. |
| K041662 |
06/18/2004 |
APNEA RISK EVALUATION SYSTEM (ARES) |
ADVANCED BRAIN MONITORING, INC. |
| K020566 |
02/20/2002 |
FUJIREBIO DIAGNOSTICS CA 19-9 RIA |
FUJIREBIO DIAGNOSTICS, INC. |
| K971622 |
05/02/1997 |
MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM |
MPL TECHNOLOGIES, INC. |
| K230049 |
01/06/2023 |
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING |
TTK Healthcare Limited |
| K213547 |
11/08/2021 |
SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla |
TTK Healthcare Limited |
| K031291 |
04/23/2003 |
CDR PANX, MODEL 4792 |
SCHICK TECHNOLOGIES, INC. |
| K152040 |
07/22/2015 |
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) |
ADVANCED BRAIN MONITORING, INC. |
| K153412 |
11/25/2015 |
Sleep Profiler |
ADVANCED BRAIN MONITORING, INC. |
| K202403 |
08/21/2020 |
SKORE (Colors & Flavors), SKORE (Colors) |
TTK Healthcare Limited |
| K970537 |
02/12/1997 |
REXTON MODEL 48 AND 49PP |
REXTON, INC. |
| K122285 |
07/30/2012 |
TABLET COMMANDER |
CARDIOCOM LLC |
| K970327 |
01/28/1997 |
SCLERAL SHELL |
SOUTHWEST ARTIFICIAL EYES, INC. |
| K970318 |
01/28/1997 |
OCULAR CONFORMER |
SOUTHWEST ARTIFICIAL EYES, INC. |
| K955126 |
11/09/1995 |
LMI BILIARY CATHETER |
LUCAS MEDICAL, INC. |
| K955125 |
11/09/1995 |
LMI OCCLUSION CATHETER |
LUCAS MEDICAL, INC. |
| K955499 |
12/01/1995 |
LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER |
LUCAS MEDICAL, 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. |
| K101044 |
04/14/2010 |
RETRIEVE IMPLANT CEMENT |
PARKELL, INC. |
| K022097 |
06/27/2002 |
THERMIQUE |
PARKELL, INC. |
| K002195 |
07/20/2000 |
FORAMATRON V, MODEL D680 |
PARKELL, INC. |
| K063003 |
10/02/2006 |
AURORA |
PARKELL, INC. |
| K113839 |
12/28/2011 |
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE |
PARKELL, INC. |
| K073698 |
12/31/2007 |
SECURE |
PARKELL, INC. |
| K080549 |
02/27/2008 |
DURAFINISH ALL-CURE, MODEL S296 |
PARKELL, 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 |
| K971829 |
05/16/1997 |
MIS ELECTROSURGICAL ELECTRODE |
E-TEK, INC. |
| K031302 |
04/24/2003 |
SUSTAIN SPACER |
GLOBUS MEDICAL INC. |
| K202675 |
09/15/2020 |
InRoad« Dental Synthetic Bone Graft |
Osteogene Tech Corp |
| K012031 |
06/28/2001 |
MODIFICATION TO THERMAL ANGEL |
ESTILL MEDICAL TECHNOLOGIES, INC. |
| K223182 |
10/11/2022 |
Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy |
WorldWork S.R.L |
| K172799 |
09/18/2017 |
Positional Sleep Assessment System (PoSAS) software |
Advanced Brain Monitoring |
| K091268 |
04/30/2009 |
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS |
HOSPIRA, INC. |
| K081412 |
05/20/2008 |
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
HOSPIRA, INC. |
| K050263 |
02/04/2005 |
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU |
M.O.C.O.M. SRL |
| K160591 |
03/01/2016 |
D.O.R.C. Disposable Cryo Probe |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
| K142877 |
10/01/2014 |
EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
| K081631 |
06/11/2008 |
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS |
SINTEA BIOTECH, INC. |
| K101886 |
07/06/2010 |
DSC/ALF SPINAL SYSTEM |
SINTEA PLASTEK, LLC |
| K112611 |
09/07/2011 |
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS |
SINTEA PLASTEK, LLC |
| K082679 |
09/15/2008 |
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X |
SINTEA BIOTECH, INC. |
| K112861 |
09/30/2011 |
SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM |
SINTEA PLUSTEK, LLC |
| K201680 |
06/22/2020 |
NuFACE Mini Plus |
Carole Cole Company |
| K201782 |
06/30/2020 |
NuFace Trinity Plus Device |
Carol Cole Company dba NuFACE |
| K201906 |
07/09/2020 |
Trinity ELE Plus and Trinity ELE Plus Pro |
Carol Cole Company dba NuFACE |
| K221322 |
05/06/2022 |
CUSTMBITE Snoring System |
Dental Choice Holdings LLC |
