FDA 510(k) Applications Submitted by Li Ma

FDA 510(k) Number Submission Date Device Name Applicant
K242192 07/26/2024 Disposable Sphincterotome Beijing ZKSK Technology Co.,Ltd.
K130760 03/20/2013 ELECTROSURGICAL GENERATOR BEIJING JINHENGWEI TECHNOLOGY DEVELOPMENT CO., LTD
K201179 05/01/2020 GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable Covidien llc
K241227 05/02/2024 RHYTHMIA HDxÖ Mapping System Boston Scientific Corporation
K970767 03/03/1997 CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH CUSTOM SERVICES INTL., INC.
K970792 03/04/1997 INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE TITAN CONDOMS
K970791 03/04/1997 INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY CUSTOM SERVICES INTL., INC.
K972427 06/27/1997 INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK CUSTOM SERVICES INTL., INC.
K972430 06/27/1997 EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 CUSTOM SERVICES INTL., INC.
K972429 06/27/1997 INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 CUSTOM SERVICES INTL., INC.
K972428 06/27/1997 EXTRAWEAR, GENTLEMEN'S CHOICE CUSTOM SERVICES INTL., INC.
K963322 08/12/1996 OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN CUSTOM SERVICES INTL., INC.
K963319 08/12/1996 OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN CUSTOM SERVICES INTL., INC.
K963321 08/12/1996 OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN CUSTOM SERVICES INTL., INC.
K191122 04/29/2019 3M RelyX Pediatric Resin Modified Glass Ionomer Cement 3M ESPE Dental Products
K152336 08/19/2015 HEX tanning booth J & B PRODUCTS LTD DBA HEX TANNING
K982672 07/31/1998 COLLEAGUE PUMP SYRINGE ADAPTER SET BAXTER HEALTHCARE CORP.
K983294 09/21/1998 ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 BAXTER HEALTHCARE CORP.
K003245 10/17/2000 HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML BAXTER HEALTHCARE CORP.
K052883 10/13/2005 CARDIOSERVER DATRIX
K053083 11/02/2005 DATRIX CARDIO WIFI ELECTROCARDIOGRAPH DATRIX
K090804 03/25/2009 NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD INNOMED TECHNOLOGIES INC./RESPCARE INC.
K162840 10/11/2016 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 Roche Diagnostics
K143534 12/12/2014 Elecsys CA-125 II assay ROCHE PROFESSIONAL DIAGNOSTICS
K150712 03/19/2015 LTM-Perforated Surgical Mesh LifeCell Corporation
K981294 04/09/1998 ODYSSEY INSTRUMENTATION SYSTEM AUTOMATA INSTRUMENTATION, INC.
K992431 07/21/1999 NEO-2 METER AUTOMATA INSTRUMENTATION, INC.
K974127 11/03/1997 HYDRA METER AUTOMATA INSTRUMENTATION, INC.
K955298 11/20/1995 PHOENIX DIALYSATE METER AUTOMATA MEDICAL INSTRUMENTATION, INC.
K173844 12/19/2017 Titan Ag 200 Specialty Fibres and Materials Ltd
K140208 01/28/2014 FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII EDWARDS LIFESCIENCES, LLC.
K100569 03/01/2010 MERIT EMBOLECTOMY CATHETER MODEL ASAP100 MERIT MEDICAL SYSTEMS, INC.
K162995 10/27/2016 Ibis« Pedicle Screw System Ortho Development Corporation
K030245 01/24/2003 NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K971356 04/11/1997 POWDER FREE SYNTHETIC EXAMINATION GLOVES ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K021412 05/03/2002 LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K991686 05/17/1999 LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K031913 06/20/2003 VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K031944 06/24/2003 VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K041745 06/28/2004 VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K954153 09/05/1995 ARISTA VINYL EXAMINATION GLOVES ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K002745 09/05/2000 VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K002746 09/05/2000 VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K022987 09/09/2002 LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K023072 09/16/2002 POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K013320 10/05/2001 BLUE LATEX EXAMINATION GLOVES, POWDER FREE ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K023754 11/06/2002 VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E ARISTA LATINDO INDUSTRIAL, LTD. P.T.
K023753 11/08/2002 VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E ARISTA LATINDO INDUSTRIAL LTD. P.T
K111191 04/28/2011 AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE WET NOSE TECHNOLOGIES, LLC
K221974 07/05/2022 EpiFinder Omeq Medical Ltd.
K040197 01/29/2004 EAGLE ANTERIOR CERVIAL PLATE SYSTEM DEPUY ACROMED
K030383 02/05/2003 MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS DEPUY ACROMED
K050675 03/16/2005 EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE DEPUY SPINE, INC.
K080828 03/25/2008 MOUNTAINEER OCT SPINAL SYSTEM DEPUY SPINE, INC.
K010972 04/02/2001 ISOLA BAND CLAMP DEPUY ACROMED
K001105 04/05/2000 MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS DEPUY ACROMED
K021148 04/10/2002 MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD DEPUY ACROMED
K011182 04/18/2001 MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS DEPUY ACROMED
K021335 04/26/2002 MONARCH SPINE SYSTEM DEPUY ACROMED
K031635 05/27/2003 DEPUY ACROMED VBR SYSTEM DEPUY ACROMED
DEN190029 06/03/2019 Acumen Assisted Fluid Management (AFM) Software Feature Edwards Lifesciences
K021879 06/07/2002 CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) DEPUY ACROMED
K021880 06/07/2002 CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) DEPUY ACROMED
K041722 06/24/2004 MODIFICATION TO VBR SPINAL SYSTEM DEPUY SPINE, INC.
K022285 07/15/2002 MODIFICATION TO ISOLA SPINAL SYSTEM DEPUY ACROMED
K092473 08/12/2009 EXPEDIUM SPINE SYSTEM DEPUY SPINE,INC
K002607 08/22/2000 MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS DEPUY ACROMED
K012916 08/30/2001 FRONTIER ANTERIOR SCOLIOSIS SYSTEM DEPUY ACROMED, INC.
K012971 09/05/2001 ISOLA SPINAL SYSTEMS DEPUY ACROMED
DEN160044 09/26/2016 Acumen Hypotension Prediction Index (HPI) Feature Software Edwards Lifesciences LLC
K052746 09/30/2005 CONCORDE VBR SPINAL SYSTEM DEPUY SPINE, INC.
K013296 10/02/2001 MOSS MIAMI SPINAL SYSTEMS DEPUY ACROMED
K013295 10/02/2001 TIMX SPINAL SYSTEMS DEPUY ACROMED
K013294 10/02/2001 MONARCH SPINAL SYSTEMS DEPUY ACROMED
K023438 10/15/2002 MODIFICATION TO MONARCH SPINE SYSTEM DEPUY ACROMED
K013441 10/17/2001 ISOLA POLYAXIAL WASHER DEPUY ACROMED
K203224 11/02/2020 Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform Edwards Lifesciences, LLC
K023804 11/14/2002 MOSS MIAMI SPINAL SYSTEM PIN NUT DEPUY ACROMED
K183646 12/26/2018 Acumen Hypotension Prediction Index û EV1000 Clinical Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index û HemoSphere Advanced Monitoring Platform - Pressure Edwards Lifeciences, LLC
K024348 12/30/2002 MONARCH SPINE SYSTEM DEPUY ACROMED
K140967 04/14/2014 FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK Insightra Medical
K170442 02/14/2017 Cranial Drill Bits and Accessories Ad-Tech Medical Instrument Corporation
K191186 05/03/2019 Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode Ad-Tech Medical Instrument Corporation
K181544 06/12/2018 Anchor Bolt (as an accessory to Depth Electrodes) Ad-Tech Medical Instrument Corporation
K152547 09/08/2015 DNAP Electrode Ad-Tech Medical Instrument Corporation
K152769 09/25/2015 FREMAP ELECTRODE AD-TECH MEDICAL INSTRUMENT CORPORATION
K163355 11/30/2016 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes Ad-Tech Medical Instrument Corporation
K953925 08/18/1995 FINE GRAIN CAST COBALT CHROMIUM HIP STEMS BIOMET, INC.
K130893 04/01/2013 XPERCT REL. 3 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K251397 05/06/2025 Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System Philips Medical Systems Nederland B.V.
K151598 06/12/2015 VesselNavigator Rel. 1.0 PHILIPS MEDICAL SYSTEMS NEDERLAND BV
K132147 07/11/2013 2D PERFUSION PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K212175 07/12/2021 DynaCAD Invivo Corporation
K132305 07/24/2013 STENTBOOST REL. 4 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K142126 08/04/2014 EP NAVIGATOR REL. 5.0 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K142273 08/15/2014 EmboGuide PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K192259 08/21/2019 Philips IntelliSite Pathology Solution Philips Electronics Nederland B.V.
K232762 09/08/2023 dS Breast Coil 7ch 1.5T Invivo Corporation (Business Trade Name: Philips)
K233204 09/28/2023 Philips IntelliSite Pathology Solution 5.1 Philips Medical Systems Nederland B.V.
K203845 12/31/2020 Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V.


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