FDA 510(k) Applications Submitted by An Kwon Ho

FDA 510(k) Number Submission Date Device Name Applicant
K172871 09/21/2017 SpineKure Kyphoplasty System Hanchang Co., Ltd.
K102040 07/19/2010 PATIENT MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD.
K051619 06/17/2005 LIPOPROTEIN FOR MULTIPLE ANALYTES BAYER HEALTHCARE, LLC
K051693 06/23/2005 MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM BAYER HEALTHCARE, LLC
K150526 03/02/2015 Optilite IgG4 Kit THE BINDING SITE GROUP LTD
K150658 03/13/2015 Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit THE BINDING SITE GROUP LTD
K161854 07/06/2016 Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS THE BINDING SITE GROUP LTD
K172613 08/31/2017 Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit The Binding Site Group Ltd.
K142735 09/23/2014 The Optilite IgG3 kit THE BINDING SITE GROUP LTD
K050374 02/14/2005 ADVIA IMS LITHIUM ASSAY BAYER HEALTHCARE, LLC
K050632 03/09/2005 ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY BAYER HEALTHCARE, LLC
K030804 03/13/2003 BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR BAYER HEALTHCARE, LLC
K030801 03/13/2003 BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL BAYER HEALTHCARE, LLC
K061137 04/24/2006 ADVIA IMS CPSA CONTROL BAYER HEALTHCARE, LLC
K061139 04/24/2006 BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS BAYER HEALTHCARE, LLC
K041133 04/30/2004 MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER BAYER HEALTHCARE, LLC
K051265 05/16/2005 ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY BAYER HEALTHCARE, LLC
K031644 05/27/2003 BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL BAYER HEALTHCARE, LLC
K031857 06/16/2003 ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY BAYER DIAGNOSTICS CORP.
K042015 07/27/2004 ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE BAYER HEALTHCARE, DIAGNOSTICS DIVISION
K052163 08/09/2005 ADVIA IMS GLUCOSE ASSAY BAYER HEALTHCARE, LLC
K032525 08/15/2003 BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER BAYER HEALTHCARE, LLC
K052242 08/17/2005 ADVIA CHEMISTRY MICROALBUMIN CONTROLS BAYER HEALTHCARE LLC
K042251 08/20/2004 BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM BAYER HEALTHCARE, LLC
K052503 09/13/2005 TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM BAYER HEALTHCARE, LLC
K042808 10/12/2004 ADVIA IMS CARBAMAZEPINE METHOD BAYER HEALTHCARE, LLC
K042807 10/12/2004 ADVIA IMS VALPROIC ACID METHOD BAYER HEALTHCARE, LLC
K033379 10/22/2003 BAYER SPECIAL CHEMISTRY CONTROLS BAYER DIAGNOSTICS CORP.
K033380 10/22/2003 BAYER SPECIAL CHEMISTRY CALIBRATORS BAYER DIAGNOSTICS CORP.
K053020 10/26/2005 TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER HEALTHCARE, LLC
K023840 11/18/2002 ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 BAYER DIAGNOSTICS CORP.
K023841 11/18/2002 AMMONIA ASSAY FOR THE ADVIA 1650 BAYER DIAGNOSTICS CORP.
K033791 12/04/2003 BAYER SPECIFIC PROTEIN REFERENCE SERUM BAYER HEALTHCARE, LLC
K111636 06/13/2011 REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM GUNNELL, INC.
K010472 02/20/2001 PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 THOMSON & NIELSEN ELECTRONICS, LTD.
K110891 03/30/2011 THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER LEMAITRE VASCULAR INC.
K121415 05/11/2012 MOLLRING MULTITASC LEMAITRE VASCULAR, INC.
K121839 06/22/2012 UNBALLOON NON-OCCLUSIVE MODELING CATHETER LEMAITRE VASCULAR INC.
K111884 07/01/2011 OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME LEMAITRE VASCULAR, INC.
K132022 07/01/2013 LEMAITRE 8F OCCLUSION CATHETER LEMAITRE VASCULAR, INC.
K132047 07/02/2013 LEMILLS VALVULOTOME LEMAITRE VASCULAR, INC.
K133026 09/26/2013 UNBALLOON NON-OCCLUSION MODELING CATHETER LEMAITRE VASCULAR, INC.
K103080 10/19/2010 ALBOGRAFT VASCULAR PROSTHESIS LEMAITRE VASCULAR, INC.
K053325 12/01/2005 MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 MEDIWATCH LTD
K033906 12/17/2003 PORTASCAN BLADDER SCANNER, MODEL PA00146 MEDIWATCH PLC
K110905 03/31/2011 TOTAL SHOULDER SYSTEM SHOULDER INNOVATIONS, LLC
K121178 04/18/2012 TRANSCORP ACIF SYSTEM TRANSCORP, INC.
K111596 06/08/2011 TOTAL SHOULDER SYSTEM SHOULDER INNOVATIONS, LLC
K092695 09/02/2009 TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM TRANSCORP, INC.
K092794 09/11/2009 TRANSCORP ACIF SYSTEM TRANSCORP, INC.
K102670 09/16/2010 TOTAL SHOULDER SYSTEM SHOULDER INNOVATIONS, LLC
K113352 11/14/2011 TRANSCORP SPINAL ACCESS SYSTEM TRANSCORP, INC.
K200431 02/21/2020 3D GraftRasp System SurGenTec
K230446 02/21/2023 TiLink-L SI Joint Fusion System Surgentec, LLC
K230857 03/29/2023 TiLink-P SI Joint Fusion System Surgentec, LLC
K211855 06/16/2021 Ion Facet Screw System SurGenTec, LLC
K231831 06/22/2023 TiLink-L Joint Fusion System SurGenTec
K201900 07/08/2020 3D GraftRasp System SurGenTec
K971710 05/08/1997 ULTRACON ULTRAFILTRATOR QUANTIC BIOMEDICAL, INC.
K181397 05/29/2018 DualX Innovasive, Inc.
K211740 06/07/2021 DualX Amplify Surgical, Inc.
K181995 07/26/2018 Chiral Surgical Pedicle Screw System Chiral Surgical
K192434 09/05/2019 DualX Lumbar Intervertebral Body Fusion Device Amplify Surgical Inc
K973488 09/15/1997 LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K070262 01/26/2007 ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K060286 02/03/2006 TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K000928 03/22/2000 QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K000930 03/22/2000 GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K971638 05/02/1997 CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K971637 05/02/1997 COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K971636 05/02/1997 RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K971635 05/02/1997 AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K971633 05/02/1997 PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K971631 05/02/1997 CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K971632 05/02/1997 TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K972030 06/02/1997 STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS OXOID, LTD.
K982523 07/20/1998 SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K982520 07/20/1998 CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K982519 07/20/1998 LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K982517 07/20/1998 CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K982526 07/20/1998 SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K982524 07/20/1998 AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K982528 07/20/1998 NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K982634 07/28/1998 DRYSPOT INFECTIOUS MONONUCLEOSIS KIT OXOID, LTD.
K982669 07/31/1998 OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K012588 08/10/2001 OXOID PYLORI TEST KIT, MODEL DR0130M OXOID, LTD.
K042157 08/10/2004 DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K973489 09/15/1997 LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K973479 09/15/1997 CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K973487 09/15/1997 CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K983718 10/21/1998 MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K984036 11/12/1998 NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K974394 11/20/1997 ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K193250 11/25/2019 Irrigation Tubing with CO2 or Air KeyMed (Medical and Industrial Equipment) Ltd.
K984513 12/18/1998 TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K984608 12/28/1998 GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD.
K180631 03/09/2018 Silk Voice Sofregen Medical, Inc.
K172545 08/23/2017 SERI Contour Sofregen Medical, Inc.
K181592 06/18/2018 RAIN Sheath Transradial Cordis Corporation
K202650 09/14/2020 Medical disposable face mask non sterile Guangdong Zhong Ling Industrial Group Co., Ltd.
K020043 01/07/2002 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B ARTHREX, INC.
K050259 02/03/2005 ARTHREX BIO-PIN ARTHREX, INC.
K050358 02/14/2005 ARTHERX CORKSCREW FT II SUTURE ANCHOR ARTHREX, INC.
K110455 02/15/2011 KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS KIMBERLY-CLARK CORP.
K060478 02/23/2006 ARTHREX BIO-COMPRESSION SCREW ARTHREX, INC.
K050749 03/23/2005 ARTHREX TAK FAMILY ARTHREX, INC.
K011007 04/04/2001 TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 ARTHREX, INC.
K021434 05/06/2002 ARTHREX FIBERWIRE IN USP SIZES ARTHREX, INC.
K041189 05/06/2004 ARTHREX TRIMIT FAMILY ARTHREX, INC.
K011495 05/15/2001 ARTHREX BIO-POST AND WASHER ARTHREX, INC.
K041356 05/20/2004 ARTHREX TENODESIS SCREW FAMILY ARTHREX, INC.
K031666 05/29/2003 ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS ARTHREX, INC.
K041553 06/09/2004 ARTHREX SUTURE GRAFTING KIT ARTHREX, INC.
K041589 06/11/2004 ARTHREX FIBERWIRE WITH SILK ARTHREX, INC.
K061665 06/14/2006 ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT ARTHREX, INC.
K071622 06/14/2007 ARTHREX FIBERWIRE ARTHREX, INC.
K031945 06/24/2003 ARTHREX TRIMIT SCREW, MODEL AR-4161B ARTHREX, INC.
K061863 06/30/2006 ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY ARTHREX, INC.
K032098 07/08/2003 ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B ARTHREX, INC.
K022234 07/11/2002 ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B ARTHREX, INC.
K032245 07/22/2003 ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 ARTHREX, INC.
K122473 08/14/2012 TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 HILL-ROM
K062466 08/24/2006 ARTHREX INTERFERENCE SCREW ARTHREX, INC.
K072378 08/24/2007 PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 ARTHREX, INC.
K012923 08/31/2001 ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 ARTHREX, INC.
K052387 08/31/2005 ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX ARTHREX, INC.
K062747 09/14/2006 ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM ARTHREX, INC.
K023119 09/19/2002 BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B ARTHREX, INC.
K052607 09/22/2005 ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS ARTHREX, INC.
K052736 09/30/2005 ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT ARTHREX, INC.
K052901 10/14/2005 ARTHREX TENSIONLOK ARTHREX, INC.
K103150 10/26/2010 KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK KIMBERLY-CLARK
K113340 11/14/2011 KIMBERLY-CLARK CHILD'S FACEMASK KIMBERLY-CLARK
K063479 11/17/2006 ARTHREX PUSHLOCK ARTHREX, INC.
K143414 11/28/2014 Hill-Rom Wireless Connectivity Module HILL-ROM
K053338 12/01/2005 ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS ARTHREX, INC.
K023986 12/02/2002 ARTHREX OPES ELECTRODES AND ACCESSORIES ARTHREX, INC.
K063719 12/15/2006 ARTHREX CROSSPIN, MODEL AR-1964P ARTHREX, INC.
K014155 12/19/2001 OPENING/CLOSING WEDGE OSTETOMY PLATES ARTHREX, INC.
K053543 12/20/2005 ARTHREX ARTHOERESIS IMPLANT ARTHREX, INC.
K050634 03/09/2005 MODIFICATION TO: ARTHREX V-TAK ARTHREX, INC.
K071176 04/27/2007 MODIFICATION TO: ARTHREX INTERFERENCE SCREW ARTHREX, INC.
K111402 05/19/2011 KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL KIMBERLY-CLARK
K182700 09/27/2018 Nexstim Navigated Brain Therapy (NBT) System 2 Nexstim Plc
K212181 07/13/2021 ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed Phadia AB
K200814 03/30/2020 Affixus(R) Natural Nail(R) System Humeral Nail Zimmer GmbH
K231114 04/19/2023 Zimmer« Natural Nail« System Cephalomedullary Nails; Affixus« Natural Nail« Humeral Nail System Zimmer Switzerland Manufacturing GmbH
K192021 07/29/2019 NCB Polyaxial Locking Plate System Zimmer GmbH
K192217 08/15/2019 NCB Plating System Distal Femur and Proximal Tibia Zimmer GmbH
K192312 08/26/2019 Zimmer Natural Nail System Cephalomedullary Nails Zimmer GmbH
K191238 05/08/2019 Zimmer Guide Wire Devices Zimmer, Inc
K173826 12/18/2017 THP Hip Fracture Plating System Biomet, Inc.
K173646 11/27/2017 FS Ergo PaloDEx Group Oy
K041164 05/03/2004 L-TENS FUJI DYNAMICS LIMITED
K140134 01/17/2014 ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE STARBOARD MEDICAL, LLC
K111050 04/15/2011 ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR STARBOARD MEDICAL, LLC
K111282 05/06/2011 DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES STARBOARD MEDICAL, LLC
K100742 03/16/2010 EXACTECH GPS BLUE ORTHO
K162567 09/14/2016 ExactechGPS Total Shoulder Application, Equinoxe Planning Software Blue Ortho
K152764 09/24/2015 EXACTECH GPS BLUE ORTHO
K173372 10/27/2017 ExactechGPS Total Shoulder Application Blue Ortho
K150282 02/05/2015 Shaser Skin Beauty Intense Pulsed Light System Family for Acne SHASER, INC.
K140631 03/12/2014 LUMENA FH HAIR REMOVAL SYSTEM SHASER, INC.
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K111901 07/05/2011 ASA 'MPHI FAMILY DIODE LASER CYNOSURE, INC.
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K132266 07/22/2013 SHASER HRS2 RX HAIR REMOVAL SYSTEM SHASER, INC.
K142924 10/08/2014 Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family SHASER, INC.
K133201 10/17/2013 SHASER V-MINI 2 HAIR REMOVAL SYSTEM SHASER, INC.
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K043319 12/02/2004 CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES NOVALIS MEDICAL, LLC
K190122 01/25/2019 Renovis A200 PS Knee System as part of the Renovis A200 Knee System Renovis Surgical Technologies
K200328 02/10/2020 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System Kyocera Medical Technologies, Inc.
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