FDA 510(k) Applications Submitted by Le Li

FDA 510(k) Number Submission Date Device Name Applicant
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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact