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General Hospital

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

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RecordFirmDate
OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS (K141759)Oak Ridge Products, LLC2014-10-24
Sherlock 3CG Tip Positioning System Stylet (K142267)C.R. Bard, Inc.2014-10-17
Merit 10mL Syringe (K142636)Merit Medical Systems, Inc.2014-10-17
EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE (K141579)Eco Medi Glove Sdn. Bhd.2014-10-17
HALO AMBULATORY INFUSION SYSTEM (K140783)Zyno Medical, LLC2014-10-17
PICC Maximal Barrier Nursing Kit (K142616)Navilyst Medical, Inc.2014-10-14
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM (K141623)Eco Medi Glove Sdn. Bhd.2014-10-07
EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (K141510)Eco Medi Glove Sdn. Bhd.2014-10-07
PADI-LOCK (K141200)Padi-Lock, LLC2014-10-02
SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION (K141664)Rexam Healthcare2014-10-02
PRO-PICC WITH VALVE TECHNOLOGY (K141633)Medical Components, Inc.2014-09-29
STERILIZATION CASSETTE (K141616)Oticon Medical AB2014-09-23
Extension Set with BD Q-Syte Luer Access Split Septum (K142527)Acacia, Inc.2014-09-19
YUSHENG (K141108)Zibo Yusheng Plastic Products Co., Ltd.2014-09-16
WHISPERJECT AUTOINJECTOR (K141384)Scandinavian Health Limited2014-09-12
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE (K140050)Hartalega Sdn Bhd2014-09-12
NOVAGUARD S A SAFETY SYSTEM (K141464)West Pharmaceutical Services2014-09-10
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130742)Dahoon Plastic Co., Ltd.2014-09-10
GLOBE-TROTTER GT5400 (K141565)Draeger Medical Systems, Inc.2014-09-10
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K131340)Made Plastic Co., Ltd.2014-09-09
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) (K141244)North American Science Assoc., Inc.2014-09-09
BIOMET GRAFT DELIVERY SYRINGES (K140710)Biomet Spine (Aka Ebi, LLC)2014-09-04
RHINIX NASAL FILTER (K134003)Rhinix Aps2014-09-04
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE (K141590)Eco Medi Glove Sdn. Bhd.2014-09-03
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE (K140418)Wrp Rubber Products Sdn Bhd2014-09-03
SELEC-3 I.V.ADMINISTRATION SET (K142097)Biomedix, Inc.2014-08-29
NIO -INTRAOSSEOUS DEVICE (K142086)Waismed, Ltd.2014-08-28
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM (K141762)Biomet, Inc.2014-08-27
STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (K133549)Steritec Products Mfg Co, Inc.2014-08-27
LITONG POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES (K141239)Zibo Litong Plastic Products Co., Ltd.2014-08-27
AOK POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K141307)Shijiazhuang Aok Plastic Co., Ltd.2014-08-27
RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K141305)Shijiazhuang Richful Plastic Co., Ltd.2014-08-27
GENESIS REUSABLE RIGID CONTAINER SYSTEM (K140850)Carefusion 2200, Inc.2014-08-27
POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR (K141021)Hl Rubber Industries Sdn Bhd2014-08-26
BASAL DIGITAL THERMOMETER (K141505)K-Jump Health Co., Ltd.2014-08-26
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (K133322)Steritec Products Mfg Co, Inc.2014-08-25
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS (K142036)B.Braun Medical, Inc.2014-08-25
MEDLINE ANTI-EMBOLISM STOCKING (K141127)Medline Industries, Inc.2014-08-21
ALARIS SYSTEM WITH GUARDRAILS SUITE MX (K133532)Carefusion 303, Inc.2014-08-21
BELTER INFRA-RED EAR THERMOMETER (K140681)Shenzhen Belter Health Measurement and Analysis TE2014-08-21
NEXUS MIDLINE CT CATHETER (K140270)Health Line International Corporation2014-08-20
OPA 30 SOLUTION (K140703)Ciden Technologies, LLC2014-08-19
SOLUTION SET/EXTENSION SET (K142011)Baxter Healthcare Corporation2014-08-18
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM (K130720)Synthes (USA) Products, LLC2014-08-14
3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER (K140392)3M Company2014-08-13
0.9% SODIUM CHLORIDE FLUSH SYRINGE (K133685)Am USA2014-08-13
BAHADIR STERILIZATION TRAYS (K131407)Bahadir USA Corp.2014-08-12
BLUE NITRILE POWDER FREE EXAM GLOVES (K133325)Shandong Xinshi Medical Products Co., Ltd.2014-08-08
SPORVIEW PLUS BI TEST PACK (K140620)Crosstex International2014-08-07
KIMGUARD ONE-STEP STERILIZATION WRAP (K141612)Kimberly-Clark Health Care2014-08-07
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (K131384)Kericure, Inc.2014-08-07
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE (K133168)Wrp Asia Pacific Sdn. Bhd.2014-08-07
INTRAVASCULAR ADMINISTRATION SET (K140175)Delta Med Spa2014-08-05
Terumo Pen Injector Needle 34 (K140516)Kofu Factory of Terumo Corp.2014-08-05
TURBO-JECT PICC SETS (K141818)Cook Corporated2014-08-05
SAPPHIRE ADMINISTRATION SET (K141834)Q Core Medical , Ltd.2014-08-05
SMC ACUPUNCTURE NEEDLE (K141473)Smc Intl., Inc.2014-08-01
ENDOSCOPE STERILIZATION TRAY (K133942)Intuitive Surgical2014-08-01
LEADERFLEX (K141026)Vygon2014-07-30
ELCAM STOPCOCKS AND MANIFOLDS (K141254)Elcam Medical Acal2014-07-30
CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT (K141749)Facet Technologies, LLC2014-07-29
KIMGUARD ONE-STEP STERILIZATION WRAP (K141071)Kimberly-Clark Health Care2014-07-28
V-PRO STERILIZATION TRAY/ STERILIZATION MAT (K140494)STERIS Corporation2014-07-25
0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE (K141311)Becton, Dickinson and Company2014-07-25
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 (K141193)Smiths Medical Asd, Inc.2014-07-25
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) (K140890)Hartalega NGC Sdn. Bhd.2014-07-24
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM (K140498)STERIS Corporation2014-07-24
COLONGLIDE LUBRICANT (K141028)Pediatric Pharmaceuticals, Inc.2014-07-24
MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS (K130097)American Medical Manufacturing, Inc./ Advanced Med2014-07-22
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING (K140487)STERIS Corporation2014-07-22
THE BELMONT RAPID INFUSER (K141654)Belmont Instrument Corporation2014-07-18
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES (K133699)Pt. Smartglove Indonesia2014-07-18
ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM (K140504)Vascular Pathways, Inc.2014-07-17
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES (K140499)STERIS Corporation2014-07-17
VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL (K140515)STERIS Corporation2014-07-17
EXAMINATION GLOVES (K140316)Hl Rubber Industries Sdn Bhd2014-07-11
MARATHON NO STING LIQUID SKIN PROTECTANT (K133443)Advanced Medical Solutions (Plymouth), Ltd.2014-07-10
ETEX MIXING AND DELIVERY SYSTEM (K141245)Etex Corporation2014-07-09
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE (K141102)Hospira, Inc.2014-07-08
WIRELESS THERMOMETER (K132761)Raiing Medical Company2014-07-08
POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) (K140816)Better Care Plastic Technology Co., Ltd.2014-07-08
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE (K141273)Welldoc, Inc.2014-07-08
CT MIDLINE (K141151)Medcomp (Medical Components, Inc.)2014-07-08
EZ-IO INTRAOSSEOUS INFUSION SYSTEM (K141117)Vidacare, LLC2014-07-08
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK (K133689)Pt. Medisafe Technologies2014-07-03
INFANT INCUBATOR (K132543)Bistos Co., Ltd.2014-07-03
POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE (K132354)Advanced Health Products, Lot 60 & 612014-06-30
SHUNTONG (K140243)Shuntong Glove Co., Ltd.2014-06-30
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (K140289)Summit Medical, Inc.2014-06-27
RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (K133193)Riverstone Resources Sdn Bhd2014-06-23
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) (K140610)Hartalega NGC Sdn. Bhd.2014-06-20
BRACCO INJEENERING TRANSFER SET (K133147)Bracco Injeneering S.A.2014-06-20
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130733)Benteng Plastic Co., Ltd.2014-06-18
EASYPOINT NEEDLE (K133635)Retractable Technologies, Inc.2014-06-17
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR (K140708)STERIS Corporation2014-06-16
CELERITY SYSYEM (K140799)Medcomp (Medical Components, Inc.)2014-06-13
VIAL2BAG DIRECT CONNECT (K140730)Medimop Medical Projects, Ltd.2014-06-12
ZHAOFENG (K140240)Zhaofeng Glove Co., Ltd.2014-06-12
TERUMO SURFLO I.V. CATHETER (K133280)Terumo (Philippines) Corporation2014-06-12
TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE (K141306)Teva Medical Ltd., Migada Plant2014-06-12
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