| K241857 |
06/27/2024 |
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) |
Dongguan Boyuan Intelligent Technology Co., Ltd. |
| K982284 |
06/30/1998 |
POWDERED GREEN LATEX EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K980167 |
01/16/1998 |
POWDERFREE LATEX EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K980285 |
01/26/1998 |
POWDERFREE BLUE NITRILE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K980280 |
01/26/1998 |
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) |
BESGLOVE MEDICARE SDN. BHD. |
| K980275 |
01/26/1998 |
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
| K980941 |
03/12/1998 |
SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
| K980940 |
03/12/1998 |
SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K980939 |
03/12/1998 |
SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K971629 |
05/02/1997 |
PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED) |
BESGLOVE MEDICARE SDN. BHD. |
| K981877 |
05/28/1998 |
NITRILE POWDERFREE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K981879 |
05/28/1998 |
POWDERED NITRILE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K981878 |
05/28/1998 |
POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
| K994082 |
12/03/1999 |
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
| K192438 |
09/06/2019 |
Rhythmia HDxTM Mapping System |
Boston Scientific Corporation |
| K232319 |
08/03/2023 |
Black Pearl Nitrile Examination Glove |
UG Global Resources Sdn. Bhd. |
| K981673 |
05/12/1998 |
POWDERFREE GREEN NITRILE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K981675 |
05/12/1998 |
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
| K981674 |
05/12/1998 |
POWDERED GREEN NITRILE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K982286 |
06/30/1998 |
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
| K982285 |
06/30/1998 |
POWDERFREE GREEN LATEX EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K980194 |
01/20/1998 |
POWDERFREE LATEX EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
| K993502 |
10/15/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
| K993500 |
10/15/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
| K993495 |
10/15/1999 |
POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
| K071364 |
05/16/2007 |
MICROTARGETING GUIDELINE 4000 |
FHC, INC. |
| K092192 |
07/21/2009 |
WAYPOINT STEREOTACTIC SYSTEM |
FHC, INC. |
| K092562 |
08/20/2009 |
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS |
FHC, INC. |
| K232241 |
07/28/2023 |
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) |
Betters(Suzhou) Medical Co., Ltd |
| K232240 |
07/28/2023 |
Microwave Ablation System (BD-GT) |
Betters (Suzhou)Medical Co., Ltd. |
| K153492 |
12/04/2015 |
CareView 1800L |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
| K201932 |
07/13/2020 |
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) |
CareRay Digital Medical System Co., Ltd. |
| K202995 |
10/01/2020 |
X-ray Flat Panel Detectors/CareView 3600RF |
CareRay Digital Medical System Co., Ltd. |
| K153058 |
10/21/2015 |
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
| K193173 |
11/18/2019 |
CareView 1800Le |
CareRay Digital Medical System Co., Ltd. |
| K151074 |
04/22/2015 |
Magnetic Reasonance Imaging System |
JIANGSU MAGSPIN INSTRUMENT CO.,LTD |
| K130750 |
03/19/2013 |
RHYTHMIA MAPPING SYSTEM |
RHYTHMIA MEDICAL, INC |
| K122461 |
08/13/2012 |
RHYTHMIA MAPPING CATHETER |
RHYTHMIA MEDICAL, INC |
| K233855 |
12/05/2023 |
AllPEP |
Enchant Tek Co. Ltd. |
| K960910 |
03/05/1996 |
INDERMIL DENTAL |
LOCTITE CORP. |
| K072534 |
09/07/2007 |
BIO-MAT 2000 |
RICHWAY INTL., INC. |
| K150806 |
03/26/2015 |
PulseFlowDF |
PulseFlow Technologies |
| K954758 |
10/16/1995 |
ROOTFORM DENTAL IMPLANT SYSTEM |
SWISS DENTAL CENTER |
| K983847 |
10/30/1998 |
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT |
GERMIPHENE CORP. |
| K150004 |
01/02/2015 |
SALVATION External Fixation System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K120019 |
01/03/2012 |
COLLAGEN RIBBON |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K120359 |
02/06/2012 |
ORTHOLOC 3DI HALLUX SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K150640 |
03/11/2015 |
RX-FIX Mini Rail External Fixator |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K140741 |
03/25/2014 |
SALVATION BEAMS AND BOLTS SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K140792 |
03/31/2014 |
SALVATION 3DI PLATING SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K140952 |
04/14/2014 |
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K141417 |
05/29/2014 |
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K121651 |
06/05/2012 |
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K141746 |
06/30/2014 |
AS20 COMPOSITE GRAFT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K162033 |
07/22/2016 |
SALVATION External Fixation System |
WRIGHT MEDICAL |
| K132656 |
08/26/2013 |
PRODENSE BONE GRAFT SUBSTITUTE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K132895 |
09/16/2013 |
WMT IMPLANTABLE K-WIRE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K213342 |
10/07/2021 |
PRO-DENSE LoVisc Bone Graft Substitute |
Wright Medical Technology, Inc. |
| K143220 |
11/10/2014 |
SIDEKICK EZ FRAME External Fixation System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K133715 |
12/05/2013 |
CHARLOTTE CLAW PLATE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K133713 |
12/05/2013 |
CHARLOTTE (TM) SNAP-OFF SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K153635 |
12/18/2015 |
SALVATION(R) External Fixation System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K200331 |
02/10/2020 |
Rapid Acoustic Pulse Device |
Soliton Inc. |
| K190542 |
03/04/2019 |
Soliton Acoustic Wave Device |
Soliton Inc. |
| K210964 |
03/31/2021 |
Resonic Rapid Acoustic Pulse Device |
Soliton Inc. |
| K201801 |
06/30/2020 |
Rapid Acoustic Pulse Device |
Soliton Inc. |
| K212502 |
08/09/2021 |
Resonic Rapid Acoustic Pulse Device |
Soliton Inc. |
| K121368 |
05/07/2012 |
NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) |
MATANG MFG. SDN. BHD. |
| K122131 |
07/18/2012 |
POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) |
MATANG MFG. SDN. BHD. |
| K072614 |
09/17/2007 |
MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE |
MATANG MFG. SDN. BHD. |
| K241220 |
05/01/2024 |
Tina-quant Lipoprotein(a) Gen.2 Molarity |
Roche Diagnostics Operations |
| K193053 |
11/01/2019 |
Tina-quant Hemoglobin A1cDx Gen.3 |
Roche Diagnostics Operations (RDO) |
| K232675 |
09/01/2023 |
Heating Tens, FT-615 |
Hivox Biotek Inc. |
| K242815 |
09/18/2024 |
POCKET TENS (EP-300) |
HIVOX BIOTEK INC. |
| K182589 |
09/20/2018 |
BD Plastipak Syringe |
Becton, Dickinson and Company |
| K052858 |
10/11/2005 |
SOOTHIES GEL PADS |
PURONXY, INC. |
| K230996 |
04/07/2023 |
Pursuant Health Kiosk (G1.D5) |
Pursuant Health |
| K170732 |
03/10/2017 |
Biomate Dental Implant System |
Biomate Medical Devices Technology Co., Ltd. |
| K061319 |
05/11/2006 |
SPECTRA SYSTEM |
IMPLANT DIRECT LLC |
| K160881 |
03/30/2016 |
Tablo Console |
OUTSET MEDICAL, INC. |
| K202267 |
08/11/2020 |
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles |
Isoray Medical, Inc. |
| K000235 |
01/27/2000 |
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
| K050207 |
01/28/2005 |
BD POSIFLOW POSITIVE DISPLACEMENT VALVE |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
| K100775 |
03/18/2010 |
BD INTIMA II CLOSED IV CATHETER |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
| K051194 |
05/10/2005 |
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 |
BECTON DICKINSON & CO. |
| K002033 |
07/05/2000 |
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
| K032843 |
09/11/2003 |
NEXIVA CLOSED IV CATHETER SYSTEM |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
| K013073 |
09/14/2001 |
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
| K042491 |
09/14/2004 |
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER |
BECTON DICKINSON & CO. |
| K013304 |
10/04/2001 |
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
| K042862 |
10/15/2004 |
BD ONECATH |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
| K013621 |
11/05/2001 |
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
| K033500 |
11/05/2003 |
BD CAREFLOW CENTRAL VENOUS CATHETER |
BECTON DICKINSON & CO. |
| K013800 |
11/15/2001 |
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
| K050016 |
01/04/2005 |
HEMOCHRON SIGNATURE ELITE |
INTERNATIONAL TECHNIDYNE CORP. |
| K010752 |
03/13/2001 |
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY |
AESCULAP, INC. |
| K092590 |
08/24/2009 |
PDS PLATES |
ETHICON, INC. |
| K091238 |
04/27/2009 |
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ |
IMPACT INSTRUMENTATION, INC. |
| K051476 |
06/03/2005 |
UNI-VENT MODEL 73X |
IMPACT INSTRUMENTATION, INC. |
| K071526 |
06/04/2007 |
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV |
IMPACT INSTRUMENTATION, INC. |
| K022062 |
06/25/2002 |
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 |
IMPACT INSTRUMENTATION, INC. |
| K032386 |
08/04/2003 |
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) |
IMPACT INSTRUMENTATION, INC. |
| K170026 |
01/03/2017 |
Radiopaque Tissue Marker |
Viscus Biologics, LLC |
| K200280 |
02/04/2020 |
MEDRAD Imaging Bulk Package Transfer Spike |
Bayer Medical Care Inc. |
| K073051 |
10/29/2007 |
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY |
MEDRAD, INC. |
| K173913 |
12/22/2017 |
MEDRAD« Imaging Bulk Package Transfer Set |
Bayer U.S. LLC |
| K010202 |
01/22/2001 |
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES |
LESLIE W. ORGAN |
| K021869 |
06/06/2002 |
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP |
DIROS TECHNOLOGY, INC. |
| K980282 |
01/26/1998 |
URESIL DILATOR WITH RADIOPAQUE MARKER |
URESIL CORP. |
| K980889 |
03/09/1998 |
URESIL NEPHRO-URETERAL STENT |
URESIL CORP. |
| K981344 |
04/09/1998 |
URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING |
URESIL CORP. |
| K972583 |
07/10/1997 |
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S |
URESIL CORP. |
| K972582 |
07/10/1997 |
URESIL GUIDEWIRE |
URESIL CORP. |
| K093653 |
11/25/2009 |
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK |
URESIL, LLC |
| K013690 |
11/07/2001 |
IDENT-A100 INTRAORAL VIDEO CAMERA |
CONFIDENT TECHNOLOGY, INC. |