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General Hospital

15,616 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
NEXUS TKO-6P LUER ACTIVATED DEVICE (K130416)Nexus Medical, LLC2013-06-12
Z-800 INFUSION SYSTEM (K130690)Zyno Medical, LLC2013-06-12
FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER (K130507)Footprint Medical, Inc.2013-06-03
IDRIVE ULTRA STERILIZATION TRAY (K130532)Covidien, Formerly US Surgical A Divison of Tyco H2013-05-30
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE (K121898)Quick-Med Technologies, Inc.2013-05-24
ATOM TRANSCAPSULE V-707 (K123937)Atom Medical Corporation2013-05-23
SANICLAVE 102, MODEL RS-SC-102 (K122978)Alternative Pioneering Research and Development2013-05-23
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD (K123084)Elcam Medical Acal2013-05-23
GETINGE 800HC- SERIES STEAM STERILIZER (K122625)Getinge Sourcing, LLC2013-05-22
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) (K120671)Cotronic Technology Limited2013-05-17
3F PRO-PICC (K123617)Medical Components, Inc.2013-05-15
SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG (K122774)Sakura Seiki Co., Ltd.2013-05-09
NMI PICC MAXIMAL BARRIER NURSING KITS (K131038)Navilyst Medical, Inc.2013-05-09
UNITOX BOTOX SYRINGE (K123710)Bio-Med USA, Inc.2013-05-09
SOL-CARE SAFETY NEEDLE (K123684)Sol-Millennium Medical2013-05-08
PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) (K131009)Proteus Digital Health, Inc.2013-05-07
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT (K123368)Hartalega Sdn Bhd2013-05-07
MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 (K122404)Repro-Med Systems, Inc. Dba Rms Medical Products2013-05-06
ARTIGLASS L. O.R. GLASS SYRINGE (K122416)Artiglass Srl2013-05-03
GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM (K120532)Getinge Sourcing, LLC2013-05-02
AGILIA INFUSION SYSTEM (K121613)Fresenius Kabi AG2013-05-01
NMI PORT (K122767)Navilyst Medical, Inc.2013-04-30
STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 (K122945)Steritec Products Mfg Co, Inc.2013-04-30
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER (K130518)Luther Needlesafe Products, Inc.2013-04-30
CG+ ARROW PICC POWERED BY ARROW VPS STYLET (K130876)Arrow International, Inc.2013-04-26
ENCIRCLE COMPRESSION THERAPY STOCKING (K122485)Encircle Medical Devices , Ltd.2013-04-23
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. (K130725)Covidien Lp, Formerly Registered AS Kendall2013-04-17
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE (K122464)Industrial Clothings, Ltd.2013-04-12
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY (K122453)Industrial Clothings, Ltd.2013-04-05
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR (K130023)Np Medical, Inc.2013-04-03
CELSITE IMPLANTABLE ACCESS PORT SYSTEMS (K130576)B. Braun Interventional Systems, Inc.2013-04-02
THERMOFINDER; THERMOCARE (K130361)Hubdic Co., Ltd.2013-04-02
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS (K123820)Bossong Hosiery Mills, Inc.2013-04-02
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER (K122221)Taidoc Technology Corporation2013-03-29
ULTRASAFE PLUS PASSIVE NEEDLE GUARD (K123743)Safety Syringes, Inc.2013-03-26
SMART-WELL INCUBATOR (K122362)Mesa Laboratories, Inc.2013-03-26
ORBIT INFUSION SET (K130468)Ypsomed AG2013-03-19
3M ATTEST(TM) AUTO-READER (K123546)3M Company2013-03-18
3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK (K121593)3M Company2013-03-15
VISIOFOCUS (K122412)Tecnimed S.R.L.2013-03-13
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K124053)Carticept Medical, Inc.2013-03-13
GETINGE 400HC-E / SERIES STEAM STERILIZER (K122071)Getinge Sourcing, LLC2013-03-12
GYNECOLOGY STERILIZATION TRAY (K121904)Smith & Nephew Inc., Endoscopy Division2013-03-11
UNI-PICC (K130034)Health Line International Corporation2013-03-08
MACLIN POWER INTRAVASCULAR ADMINISTRATION SET (K121511)Maclin Power, Inc.2013-03-07
K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) (K123344)Kawasumi Laboratories, Inc.2013-03-07
LITTLE ANGELS SWADDLING BLANKET (K123411)Bionix Development Corp.2013-03-07
MULTIPLE NAME (K123819)Top Calibre Sdn Bhd2013-03-05
JMS SAFE WING CATH (SWC) (K121488)JMS North America Corporation2013-03-05
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245)Baxter Healthcare Corp2013-03-01
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE (K123749)Kossan Latex Industries(M)Sdn Bhd2013-03-01
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES (K123869)Dehai (Shandong) Medical Gloves, Co., Ltd.2013-02-28
GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE (K121999)Draeger Medical GmbH2013-02-28
DURABLUE STERILIZATION WRAP (K123289)Cardinal Health-Medical Products and Services2013-02-28
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS (K120592)Dana Products, Inc.2013-02-27
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 (K130197)Becton, Dickinson and Company2013-02-27
ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM (K123361)Fiab Spa2013-02-27
T:CONNECT DATA MANAGEMENT SYSTEM (K122361)Tandem Diabetes Care, Inc.2013-02-22
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE (K122727)Northstar Healthcare Holdings2013-02-22
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE (K130038)Hl Rubber Industries Sdn Bhd2013-02-21
DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 (K123175)Conmed Corporation2013-02-21
INTRADERMAL ADAPTER (K123588)West Pharmaceutical Services, Inc.2013-02-19
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE (K123469)Wear Safe (Malaysia) Sdn Bhd - Facility II2013-02-19
MONOJECT 12ML SYRINGE (K130049)Nipro Medical Corporation2013-02-14
CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) (K123116)Worldmed Manufacturing Sdn. Bhd.2013-02-11
MYOSURE INTRUMENT TRAY (K121280)Hologic, Inc.2013-02-08
LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE (K123488)Puyang Linshi Health Co., Ltd.2013-02-08
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE (K121050)Becton, Dickinson & CO2013-02-07
GIRAFFE AND PANDA WARMERS (K123309)Ohmeda Medical2013-02-05
DIGITAL THERMOMTER (K122520)Taidoc Technology Corporation2013-02-05
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE (K111275)Smiths Medical Asd, Inc.2013-02-01
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR (K123757)Assurguard Sdn. Bhd.2013-02-01
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) (K122696)Cardinal Health, Inc.2013-01-31
POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K122396)Wealth on (Jiangsu) Co., Ltd.2013-01-31
GEMINI STERILZATION WRAP (K113353)Medline Industries, Inc.2013-01-31
MULTIPLE NAME (K123760)Assurguard Sdn. Bhd.2013-01-28
HEPAIRX VENTILATING AIR PURIFIER (K112728)Air Innovations, Inc.2013-01-23
DURABLUE STERILIZATION WRAP (K123857)Cardinal Health200, LLC2013-01-23
CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS (K123967)Catheter Connections, Inc.2013-01-22
TBA (K121269)Migada Plant2013-01-22
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK (K123328)Nitrilist Gloves Manufacturing Sdn Bhd2013-01-18
POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS (K121592)Tekmedic (M) Sdn Bhd2013-01-18
BD PEN NEEDLE (K123300)Becton, Dickinson & CO2013-01-18
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM (K123734)Becton Dickinson Infusion Therapy Systems, Inc.2013-01-17
ZEPHYR 'X-SERIES PATIENT TRANSFER SLED (K121929)Diacor, Inc.2013-01-17
POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) (K122408)Hongye Plastic Products Co., Ltd.2013-01-17
TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O (K122788)Northstar Healthcare Holdings2013-01-17
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S (K123874)Baxter Healthcare Corp2013-01-10
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE (K123213)Becton, Dickinson & CO2013-01-09
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET (K123868)Baxter Healthcare Corp2013-01-08
OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE (K122818)Olympus Keymed (Medical & Industrial Equipment) LT2013-01-04
PEARL DIABETES MANAGEMENT SYSTEM (K122483)Asante Solutions, Inc.2013-01-03
CG+ ARROW PICC POWERED BY ARROW VPS STYLET (K123759)Arrow International, Inc. (Subsidiary of Teleflex2013-01-03
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 (K121007)Delta Med Srl2012-12-28
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE (K121549)Siam Sempermed Corp., Ltd.2012-12-27
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 (K123017)Advanced Sterilization Products2012-12-26
VERSARATE FLOW RATE CONTROLER (K123729)Emed Technologies Corporation2012-12-21
FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE (K123085)3M Company2012-12-20
INTRAVASCULAR ADMINISTRATION SET (K121803)Acta Medical, LLC2012-12-19
FINN CHAMBERS AQUA (K123184)Smartpractice2012-12-19
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