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General Hospital

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

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RecordFirmDate
MODIFICATION TO DISPOSABLE INFUSION PUMP KIT (K071735)Symbios Medical Products, LLC2007-07-19
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 (K070461)STERIS Corporation2007-07-17
MEDICOM SELF-SEALING STERILIZATION POUCH (K070428)A.R. Medicom, Inc.2007-07-17
OHMEDA MEDICAL GIRAFFE OMNIBED (K071175)GE Healthcare2007-07-17
WELMED HYPODERMIC SYRINGE (K070936)Welmed, Inc.2007-07-16
POWDER FREE LATEX EXAMINATION GLOVES (K071322)Quality Gallant Sdn. Bhd.2007-07-13
ON THE GO SHARPS (K070577)Medport, Inc.2007-07-13
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR (K070852)Shijiazhang Hongxiang Plastic Products Co., Ltd.2007-07-13
CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER (K070578)Zen Strong Medical Technology Co., Ltd.2007-07-11
GIRAFFE AND PANDA WARMER (K070377)Ohmeda Medical2007-07-11
TERUMO 31G THINPRO INSULIN SYRINGE (K071630)Terumo Medical Corp.2007-07-11
LIFE LATCH SHARPS & BIOHAZARD CONTAINER (K071088)M&M Industries, Inc.2007-07-05
POWDER-FREE VINYL EXAMINATION GLOVES (K071022)Glormed Colombia S.A.2007-07-05
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT (K070613)AngioDynamics, Inc.2007-06-29
TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE (K063681)Mediline Italia S.R.L.2007-06-29
POWDERED LATEX EXAMINATION GLOVES (K071323)Quality Gallant Sdn. Bhd.2007-06-22
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 (K070491)K-Jump Health Co., Ltd.2007-06-21
FEEL-JECT INSULIN SYRINGE (K070917)Feel Tech2007-06-20
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING (K070639)Siam Sempermed Corp., Ltd.2007-06-15
INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM (DEN060002)Inrange Systems, Inc.2007-06-13
HYPERTHERMIA PUMP (K070654)Belmont Instrument Corp.2007-06-08
STERILIZATION POUCH WITH INDICATORS (K062704)Winner Industries (Shenzhen) Co., Ltd.2007-06-08
POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE (K070760)Derma Care Plus Products, LLC2007-06-07
GENIE, MODEL CH-200 (K070633)Icu Medical, Inc.2007-06-05
DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 (K070878)Rg Medical Diagnostics2007-06-05
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE) (K070862)Purtech Cleanroom Products Co., Ltd.2007-05-30
MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP (K070814)Confluent Surgical,Inc2007-05-30
EVICEL APPLICATION DEVICE (K070575)Omrix Biopharmaceuticals , Ltd.2007-05-29
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB (K070264)Terumo Europe N.V.2007-05-29
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES (K071222)Baxter Healthcare Corp2007-05-25
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) (K070547)Terumo Europe N.V.2007-05-25
SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR (K070595)Spsmedical Supply Corp.2007-05-24
SMARTSPONGE SYSTEM (K071355)Clearcount Medical Solutions, Inc.2007-05-24
IMM HYPODERMIC NEEDLE SET (K070801)Innovative Medical Manufacturing Co.2007-05-24
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR (K071014)Advanced Sterilization Products2007-05-24
TEXIUM SYRINGE (K071108)Cardinal Health, Alaris Products2007-05-24
POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE (K070116)Smiths Medical MD, Inc.2007-05-23
WALLABY 4 (K070180)Respironics Inc., Sleep & Home Respiratory Group2007-05-18
BODYGUARD PAIN MANAGER INFUSION SYSTEM (K070235)Caesarea Medical Electronics , Ltd.2007-05-18
SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB (K070457)Sun Scientific, LLC2007-05-16
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) (K070003)Medcomp2007-05-15
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K070861)Hong Xin Rubber Products Co., Ltd.2007-05-15
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE (K070821)Medtexx Manufacturing Sdn. Bhd.2007-05-10
4 FR SINGLE LUMEN (SL) POWERPICC CATHETER (K070996)C.R. Bard, Inc.2007-05-08
AFF (MARK I) VOLUMETRIC INFUSION PUMP (K070529)Definitive Medical Technologies, Ltd.2007-05-08
3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR (DEN060009)3M Company2007-05-08
SURFLO WINGED INFUSION SET (K070362)Terumo Europe N.V.2007-05-07
FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE (K063363)Flexicath , Ltd.2007-05-07
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT (K070615)AngioDynamics, Inc.2007-05-04
SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405) (K062784)Sejoy Electronics & Instruments Co., Ltd.2007-05-04
PRODERMA LIQUID BANDAGE (K063202)Procurement Technology Systems, LLC2007-05-02
DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES (K071019)Mesure Technology Co., Ltd.2007-04-27
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 (K070398)Hospira, Inc.2007-04-24
INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024 (K070203)Inviro Medical Devices, Inc.2007-04-23
RII INFRARED EAR THERMOMETER, MODEL TH01BN (K070976)Radiant Innovation, Inc.2007-04-20
TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP (K061756)Shen Wei (Usa), Inc.2007-04-19
COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION (K070125)Baxter Healthcare Corp2007-04-16
BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE (K062526)Multisafe Sdn. Bhd.2007-04-13
MODIFICATION TO: BODYGUARD INFUSION SYSTEM (K070718)Caesarea Medical Electronics , Ltd.2007-04-13
WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F. (K063542)Mesure Technology Co., Ltd.2007-04-10
PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES (K070519)Zhang Jia Gang Huayuan Plastic Co. , Ltd.2007-04-10
JMS PLANECTA STOPCOCK (K070143)Jms North America Corp.2007-04-10
POWERED NITRILE BLUE EXAMINATION GLOVES (K061505)Liwe Trading2007-04-09
FOAM RING PORT PROTECTOR (K062261)Inspired Ideas, Incorporated2007-04-09
GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER (K070657)Getinge Sourcing, LLC2007-04-05
POWERGROSHONG PICC CATHETER (K063848)C.R. Bard, Inc.2007-04-04
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS (K070430)Unomedical A/S2007-04-04
STERILOX LIQUID CHEMICAL STERILANT SYSTEM (K063159)Puricore, Inc.2007-04-02
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE (K063674)Animas Corp.2007-03-30
POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K070041)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-28
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K070404)Tangshan Luxiong Plastic Products Co., Ltd.2007-03-26
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW (K070038)Super Safe Plastic Products Co., Ltd.2007-03-23
POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR (K070097)Gx Corporation Sdn Bhd2007-03-23
POWDERED (WHITE) VINYL PATIENT EXAMINATION (K070027)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-22
HASELMEIER PEN (K070100)Haselmeier Sarl2007-03-21
LMT-KATH-S; LMT-KATH-I (K062308)Licher Medizintechnologie GmbH2007-03-20
SPIROS (K070532)Icu Medical, Inc.2007-03-20
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) (K063627)Smart Glove Corp. Sdn Bhd2007-03-20
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) (K062919)Shen Wei (Usa), Inc.2007-03-20
SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS (K062873)E.C.I. USA Corporation2007-03-20
CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 (K070342)American I.V. Products, Inc.2007-03-19
POWDER FREE NITRILE BLUE EXAMINATION GLOVE (K061504)Liwe Trading2007-03-19
SILVERLON DIRECT PRESSURE WOUND DRESSING (K984207)Argentum International, LLC2007-03-19
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW (K070188)Hong DI Plastic Products Co., Ltd.2007-03-19
BD HYPOINT NEEDLE (K070440)Becton, Dickinson & CO2007-03-16
SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE (K063581)Pt Mahakarya Inti Buana2007-03-15
PROCHEM EXT CHEMICAL INTEGRATOR (K062651)Raven Biological Laboratories, Inc.2007-03-15
NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES (K070072)Medtexx Manufacturing Sdn. Bhd.2007-03-15
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR (K070096)Gx Corporation Sdn Bhd2007-03-14
REPEATER PUMP II TUBE SETS (K062909)Baxa Corp.2007-03-09
POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K070026)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-07
SAF-T-SYRINGE- 0.5 AND 1ML/CC (K063340)Safety Medical International, Incorporated2007-03-06
SEKURIT SHARPS COLLECTION CONTAINER (K063722)Techen Safety, Inc.2007-03-05
TOP FINE (K063466)Daejin Tech Medical Manufacturing Co., Ltd.2007-03-02
ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES (K063776)Bright Element Sdn Bhd2007-03-02
TOP FINE INSULIN SYRINGE (K063348)Daejin Tech Medical Manufacturing Co., Ltd.2007-03-01
POWDERED VINYL PATIENT EXAMINATION GLOVES (K070145)Wuxi Shenzhou Plastic Products Co., Ltd.2007-02-28
SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K063471)Shijiazhuang Junfei Plastic Products Co., Ltd.2007-02-28
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 (K063696)Baxterhealthcare, Inc.2007-02-27
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE (K063755)Smiths Medical Asd, Inc.2007-02-27
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