FDA 510(k) Applications Submitted by Ke Li

FDA 510(k) Number Submission Date Device Name Applicant
K211260 04/26/2021 Sheng Jing Tang Surgical Mask Liaoning Shengjingtang Biotechnology Co., Ltd.
K170636 03/02/2017 Fathom-16 Steerable Guidewires Boston Scientific Corporation
K211508 05/14/2021 Steinmann Pins and Kirschner Wires Stryker GmbH
K212581 08/16/2021 VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System Stryker GmbH
K060031 01/05/2006 DEPUY MODULAR M HEADS DEPUY ORTHOPAEDICS, INC.
K052079 08/02/2005 PINNACLE CONSTRAINED ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC.
K060041 01/06/2006 TRIMED BONE PLATES TRIMED, INC.
K050681 03/16/2005 OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES TRIMED, INC.
K091156 04/21/2009 TRIMED STERILE PRODUCT TRIMED, INC.
K081348 05/14/2008 TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD TRIMED, INC.
K101375 05/17/2010 TRIMED X-FIX TRIMED, INC.
K071876 07/06/2007 CROSS.BONE TRIMED, INC.
K113369 11/15/2011 ZIMMER PERSONA KNEE SYSTEM ZIMMER INC.
K043263 11/24/2004 TRIMED OSTEOTOMY PLATE TRIMED, INC.
K093676 11/27/2009 OMNITECH LARGE, TRIMED COMPRESSION SCREW TRIMED, INC.
K020320 01/31/2002 RADIOSYSTEM/NT, MODEL 80-13020 STYKER INSTRUMENTS
K022365 07/22/2002 STRYKER NAVIGATION SYSTEM - HIP MODULE STRYKER INSTRUMENTS
K153415 11/25/2015 Reprocessed Stryker External Fixation Devices STRYKER SUSTAINABILITY SOLUTIONS
K141425 05/30/2014 ELITE + LASER SYSTEM CYNOSURE, INC.
K143105 10/29/2014 Picosure Workstation CYNOSURE, INC.
K100616 03/04/2010 KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 LIFE TECHNOLOGIES CORPORATION
K103302 11/09/2010 STEMPRO MSC SFM LIFE TECHNOLOGIES CORPORATION
K140404 02/18/2014 ELECSYS CK-MB STAT IMMUNOASSAY Roche Diagnostics
K141426 05/30/2014 ELECSYS FOLATE III Roche Diagnostics
K151786 07/01/2015 Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet Roche Diagnostics
K142021 07/25/2014 Elecsys Estradiol III CalSet Roche Diagnostics
K142127 08/04/2014 ELECSYS ESTRADIOL III CALCHECK 5 Roche Diagnostics
K152227 08/07/2015 Elecsys Cortisol II, Cortisol II CalSet ROCHE DIAGNOSTICS
K132571 08/15/2013 ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY Roche Diagnostics
K132828 09/09/2013 ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics
K162678 09/26/2016 Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl ROCHE DIAGNOSTICS
K133284 10/25/2013 ELECSYS CK-MB CALCHECK 5 Roche Diagnostics
K143284 11/17/2014 Elecsys Estradiol III Calcheck ROCHE DIAGNOSTICS
K143342 11/21/2014 Elecsys T-Uptake Calset Roche Diagnostics
K121771 06/15/2012 ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM ZIMMER, INC.
K022579 08/05/2002 STRYKER NAVIGATION SYSTEM-KNEE MODULE STRYKER LEIBINGER
K023449 10/15/2002 NON-INVASIVE PATIENT FIXATION SYSTEM STRYKER LEIBINGER
K113566 12/02/2011 OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM LIFE TECHNOLOGIES, INC.
K231461 05/19/2023 Smart Correction System (HA Half Pins) WishBone Medical, Inc.
K133834 12/17/2013 DEPUY GLOBAL UNITE SHOULDER SYSTEM DEPUY (IRELAND)
K140374 02/14/2014 MASTERGRAFT PUTTY MEDTRONIC SOFAMOR DANEK USA, INC.
K140375 02/14/2014 MASTERGRAFT PUTTY, MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK USA, INC.
K131673 06/07/2013 MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT MEDTRONIC SOFAMOR DANEK USA, INC.
K171689 06/07/2017 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology Medtronic Sofamor Danek USA, Inc.
K122513 08/17/2012 CLEARED UNDER GRAFTON II EDBM MEDTRONIC SOFAMOR DANEK, INC.
K220212 01/26/2022 BD Vacutainer« Push Button Blood Collection Set, BD Vacutainer« Push Button Blood Collection Set with Pre-Attached Holder Becton, Dickinson and Company
K153336 11/19/2015 VuePoint OCT System NUVASIVE, INCORPORATED
K060814 03/27/2006 DYNATRON ION IONTOPHORESIS ELECTRODE DYNATRONICS CORP.
K014241 12/26/2001 COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D ALSIUS CORP.
K230051 01/06/2023 14F iSLEEVEÖ Introducer Set Boston Scientific Corporation
K191774 07/02/2019 SmileAlign Orthodontic Aligner System 3D Global Biotech Inc.
K212803 09/02/2021 DailyMate Orthodontic Aligner System 3D Global Biotech Inc
K070161 01/17/2007 QUATTRO CATHETER MODEL IC4593 ALSIUS CORP.
K060308 02/07/2006 COOLGARD 3000 ALSIUS CORP.
K030421 02/10/2003 ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM ALSIUS CORP.
K091121 04/17/2009 ORTHOSTAT ORTHOCON, INC.
K051912 07/14/2005 COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B ALSIUS CORP.
K072234 08/10/2007 THERMOGARD XP THERMAL REGULATION SYSTEM ALSIUS CORP.
K052443 09/06/2005 ICY CATHETER, MODEL IC-3893A ALSIUS CORP.
K193256 11/26/2019 Anjon Bremer Halo System Anjon Holdings LLC
K063829 12/26/2006 THERMOGARD THERMAL REGULATION SYSTEM ALSIUS CORP.
K070570 02/28/2007 DIO IMPLANT SYSTEM DIO DEPARTMENT DSI, INC.
K070569 02/28/2007 SM INTERNAL./EXTERNAL IMPLANT SYSTEM DIO DEPARTMENT DSI, INC.
K070568 02/28/2007 DIO PROTEM IMPLANT SYSTEM DIO DEPARTMENT DSI, INC.
K990502 02/17/1999 PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) FLEXITECH SDN. BHD.
K990499 02/17/1999 PREPOWDERED NITRILE EXAMINATION GLOVES FLEXITECH SDN. BHD.
K990495 02/17/1999 POWDER FREE NITRILE EXAMINATION GLOVES FLEXITECH SDN. BHD.
K161048 04/14/2016 Conventus Orthopaedics Ulna Fixation System CONVENTUS ORTHOPAEDICS, INC.
K131552 05/30/2013 CONVENTUS DRS CONVENTUS ORTHOPAEDICS
K141737 06/27/2014 CONVENTUS PHS SYSTEM CONVENTUS ORTHOPAEDICS, INC.
K062794 09/18/2006 PRN THERMALCARE, MODEL 3000 AMERICAN HEALTHCARE PRODUCTS, INC.
K151379 05/22/2015 Conventus PRS System Conventus Orthopaedics, Inc
K142443 09/02/2014 Site-Rite 6 Ultrasound System with Pinpoint GT Technology C.R. Bard, Inc
K152554 09/08/2015 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology C.R. Bard, Inc.
K132942 09/19/2013 SITE-RITE VISION II ULTRASOUND SYSTEM C.R. BARD, INC.
K030190 01/21/2003 CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES SUZHOU SEN SEN MEDICAL SUPPLIES LTD.
DEN040007 08/04/2004 VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER DIGITAL ANGEL CORPORATION


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