FDA 510(k) Applications Submitted by Ma Li

FDA 510(k) Number Submission Date Device Name Applicant
K213223 09/29/2021 Multi-Band Ligator Beijing ZKSK Technology Co.,Ltd
K213222 09/29/2021 Disposable Polypectomy Snare Beijing ZKSK Technology Co.,Ltd
K213217 09/29/2021 Disposable hemoclip Beijing ZKSK Technology Co.,Ltd
K213239 09/30/2021 Endoscopic Injection Needle Beijing ZKSK Technology Co.,Ltd
K171553 05/30/2017 W&H Assistina Twin W & H Dentalwerk Buermoos GmbH
K140478 02/26/2014 AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier SAS
K132285 07/23/2013 AEQUALIS REVERSED SHOULDER PROSTHESIS TORNIER, SAS
K172925 09/25/2017 Contact Lens Case, Model: A-1, B-1 P L Overseas Limited
K153582 12/15/2015 Prometheus ChitoGauze XR PRO HEMCON MEDICAL TECHNOLOGIES, INC.
K170958 03/31/2017 ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm Tricol Biomedical Inc.
K120209 01/24/2012 PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE AMERICAN I.V. PRODUCTS, INC.
K161768 06/27/2016 LUCAS 3 Chest Compression System Jolife AB
K173553 11/16/2017 LUCAS 3 Chest Compression System Jolife AB
K100066 01/11/2010 DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 WELLDOC, INC
K041671 06/21/2004 IMAGENMD CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
K173765 12/11/2017 Surveyor Patient Monitor Mortara Instrument, Inc.
K170875 03/24/2017 da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories Intuitive Surgical, Inc.
K191043 04/19/2019 da Vinci Handheld Camera Intuitive Surgical, Inc.
K222894 09/23/2022 Invisalign System, Pre-Formed Attachment System Align Technology, Inc.
K120010 01/03/2012 CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
K962655 07/08/1996 ANEROID AND MERCURIAL SPHYGMOMANOMETERS AMERICAN DIAGNOSTIC CORP.
K012304 07/20/2001 ADC 656 ELECTRONIC STETHOSCOPE AMERICAN DIAGNOSTIC CORP.
K030073 01/08/2003 VERMED A10021 RESTING EKG TAB ELECTRODE VERMONT MEDICAL, INC.
K090180 01/23/2009 TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE VERMED, INC.
K010638 03/05/2001 NEUROPLUS, MODEL A10040, A10041, A10042, A10043 VERMONT MEDICAL, INC.
K021537 05/10/2002 MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 VERMONT MEDICAL, INC.
K161337 05/13/2016 CryoDose H or Similar NUANCE MEDICAL, LLC
K172203 07/21/2017 CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray Nuance Medical, LLC
K162218 08/08/2016 Pain FreezeÖ, Medium Stream Spray, Model #2101; Pain FreezeÖ, Mist Spray, Model #2102 NUANCE MEDICAL, LLC
K220331 02/04/2022 091 Balloon Guide Catheter InNeuroCo Inc.
K190338 02/14/2019 046 Zenith Flex InNeuroCo, Inc
K161262 05/05/2016 Super Distal Access (SDA) INNEUROCO, INC
K181354 05/22/2018 074 Zenith Flex System InNeuroCo Inc.
K171672 06/06/2017 065 Zenith, 074 Zenith InNeuroCo, Inc
K172167 07/18/2017 Zenith Flex System InNeuroCo, Inc.
K232260 07/31/2023 Thinline Sheath Introducer Inneuroco Inc.
K172468 08/15/2017 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm InNeuroCo, Inc
K173709 12/04/2017 Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm InNeuroCo, Inc
K112595 09/07/2011 COFLEX-F PARADIGM SPINE, LLC
K153302 11/13/2015 coflex-IF PARADIGM SPINE, LLC
K131279 05/06/2013 ICONACY I-HIP SYSTEM ICONACY ORTHOPEDIC IMPLANTS, LLC
K132572 08/15/2013 I-HIP TOTAL HIP SYSTEM ICONACY ORTHOPEDIC IMPLANTS, LLC
K133228 10/21/2013 ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM ICONACY ORTHOPEDIC IMPLANTS, LLC
K130995 04/10/2013 NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY NUANCE MEDICAL, LLC
K021931 06/12/2002 ENDOSCOPIC FIBEROPTIC CABLE GULF MEDICAL FIBEROPTICS
K061690 06/15/2006 SURGICAL HEADLIGHT GULF MEDICAL FIBEROPTICS
K012347 07/24/2001 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY SULZER INTRATHERAPEUTICS, INC.
K192077 08/02/2019 Tua Face Fitness / Tua Trend Face Vupiesse S.R.L
K172825 09/18/2017 MN-111 W&H Sterilization s.r.l.
K120051 01/06/2012 SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML NEPHRON PHARMACEUTICALS CORP.
K113033 10/12/2011 SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML NEPHRON PHARMACEUTICALS CORP.
K190402 02/19/2019 Triathlon Total Knee System-Additional Components Stryker Orthopaedics (aka Howmedica Osteonics Corp.)
K220838 03/22/2022 Artisan Bone Plug, Universal Cement Restrictor Howmedica Osteonics, dba Stryker Orthopaedics
K222056 07/12/2022 Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Howmedica Osteonics Corp., dba Stryker Orthopaedics
K212187 07/13/2021 Restoration« Modular Hip System Howmedica Osteonics Corp., dba Stryker Orthopaedics
K202016 07/21/2020 Dall-Miles« Cable System Howmedica Osteonics Corp., dba Stryker Orthopaedics
K172326 08/01/2017 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System Stryker Orthopaedics
K222632 08/31/2022 UHR Bipolar Implants, Restoration GAP II Implants Howmedica Osteonics Corp., dba Stryker Orthopaedics
K223069 09/30/2022 Modular Rotating Hinge Knee Systems and Compatible Components Howmedica Osteonics Corp. dba Stryker Orthopaedics
K153345 11/19/2015 Stryker Orthopaedics Hip Systems Labeling Update STRYKER ORTHOPAEDICS
K143393 11/26/2014 Triathlon Tritanium Cone Augments STRYKER ORTHOPAEDICS
K173849 12/19/2017 Triathlon Total Knee System Stryker Orthopaedics
K113565 12/02/2011 MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN EDWARDS LIFESCIENCES, LLC.
K170168 01/19/2017 Masimo Rad-97 and Accessories MASIMO CORPORATION
K110167 01/20/2011 PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) EDWARDS LIFESCIENCES, LLC.
K090165 01/22/2009 RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 MASIMO CORPORATION
K140188 01/24/2014 MASIMO ROOT MONITORING SYSTEM MASIMO CORPORATION
K150314 02/09/2015 Masimo MightySat Rx Fingertip Pulse Oximeter MASIMO CORPORATION
K100428 02/16/2010 MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER MASIMO CORPORATION
K100403 02/16/2010 MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 MASIMO CORPORATION
K160526 02/25/2016 Masimo O3 Regional Oximeter System MASIMO CORPORATION
K110597 03/02/2011 EV1000 CLINICAL PLATFORM EDWARDS LIFESCIENCES
K100617 03/04/2010 MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D MASIMO CORPORATION
K090662 03/12/2009 MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP MASIMO CORPORATION
K160940 04/04/2016 Masimo Disposable Transflectance Forehead Sensor Masimo Corporation
K071047 04/13/2007 MASIMO PATIENT SAFETY NET MASIMO CORPORATION
K091057 04/13/2009 MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES MASIMO CORPORATION
K101031 04/13/2010 MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 MASIMO CORPORATION
K171121 04/17/2017 Masimo Root Monitoring System and Accessories Masimo Corporation
K091241 04/27/2009 MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER MASIMO CORPORATION
K081659 06/12/2008 RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L MASIMO CORPORATION
K151644 06/18/2015 Masimo Root Vital Signs Monitoring System and Accessories MASIMO CORPORATION
K101896 07/07/2010 MASIMO LNCS/M-LNCS OXIMETRY SENSORS MASIMO CORPORATION
K082052 07/21/2008 MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK MASIMO CORPORATION
K122381 08/06/2012 NEXFIN MODEL 2 EDWARDS LIFESCIENCES, LLC.
K142394 08/27/2014 Masimo Root Monitoring System and Accesories MASIMO CORPORATION
K092838 09/15/2009 MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 MASIMO CORPORATION
K162603 09/19/2016 Masimo O3 Regional Oximeter System MASIMO CORPORATION
K162675 09/26/2016 Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter MASIMO CORPORATION
K103094 10/19/2010 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC.
K073024 10/26/2007 MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES MASIMO CORPORATION
K153225 11/06/2015 Masimo Root Monitoring System and Accessories Masimo Corporation
K083622 12/08/2008 LNCS OXIMETRY SENSORS MASIMO CORPORATION
K083719 12/15/2008 LNCS OXIMETRY SENSORS MASIMO CORPORATION
K094046 12/31/2009 LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS MASIMO CORPORATION
K232569 08/24/2023 CAREMIBRAIN General Equipment for Medical Imaging, S.A.
K120884 03/23/2012 PERICAM PSI PERIMED AB
K131253 05/02/2013 PERIFLUX 6000 PERIMED AB
K213442 10/25/2021 Extroducer Infusion Catheter System Smartwise Sweden AB
DEN110012 04/13/2011 APTIMA TRICHOMONAS VAGINALIS ASSAY GEN-PROBE INCORPORATED
K122062 07/13/2012 APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER GEN-PROBE, INC.
K052513 09/14/2005 BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 DELTA ENTERPRISE CORPORATION
K152930 10/05/2015 PeriFlux6000 PERIMED AB
K013133 09/19/2001 NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 NORDIX, INC.
K142419 08/28/2014 Mini and Micro Fragments Reconstruction System-NEOFIX NEOORTHO PRODUCTOS ORTHOPEDICOS S/A
K162874 10/13/2016 Cannulated Screws Neoortho Neoortho Produtos Ortopedicos S/A
K180204 01/24/2018 CranioMaxillofacial Fixation (CMF) System - CMF Visionare Visionare LLC
K113705 12/16/2011 PINTLER PATIENT WARMING SYSTEM PINTLER MEDICAL
K090844 03/27/2009 BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K081008 04/10/2008 BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS Lin-Zhi International, Inc.
K050988 04/19/2005 OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K062242 08/02/2006 METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K063024 10/02/2006 LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K142894 10/03/2014 TCS Blend Thermoplastic Comfort Systems, Inc.
K053060 10/31/2005 TCS UNBREAKABLE THERMOPLASTIC COMFORT SYSTEMS, INC.
K180513 02/27/2018 CustomizedBone Service Fin-Ceramica Faenza S.p.A
K171507 05/23/2017 CustomizedBone Service Fin-ceramica faenza spa
K193547 12/20/2019 CustomizedBone Service Fin-Ceramica Faenza Spa
K210127 01/19/2021 iQ200 System, iChemVELOCITY Automated Urine Chemistry System Beckman Coulter, Inc.
K060107 01/13/2006 MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS EXACTECH, INC.
K110327 02/03/2011 LDR SPINE ROI-A INTERBODY FUSION SYSTEM LDR SPINE USA
K070479 02/20/2007 EXACTECH NOVATION CROWN CUP AND LINERS EXACTECH, INC.
K051335 05/23/2005 ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS EXACTECH, INC.
K061454 05/25/2006 EXACTECH EQUINOXE SHOULDER STEMS EXACTECH, INC.
K081622 06/10/2008 UNIVERSAL CLAMP STAINLESS STEEL SYSTEM ABBOTT SPINE, INC.
K061668 06/14/2006 OPTECURE +CCC EXACTECH, INC.
K051682 06/23/2005 EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM EXACTECH, INC.
K052787 10/03/2005 ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) EXACTECH, INC.
K123134 10/05/2012 EASYSPINE SYSTEM LDR SPINE USA INC.
K063279 10/31/2006 NOVATION SPLINED RDD FEMORAL STEMS EXACTECH, INC.
K113285 11/07/2011 LDR SPINE USA AVENUE L INTERBODY FUSION LDR SPINE USA INC.
K073202 11/13/2007 ARDIS SPACER ABBOTT SPINE, INC.
K063685 12/12/2006 OPTECURE; OPTECURE + CCC EXACTECH, INC.
K172457 08/14/2017 Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM Deltex Medical Limited
K072053 07/26/2007 SMARTBLOCK PAIN PUMP MEDICAL FLOW SYSTEMS LTD
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