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General Hospital

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

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RecordFirmDate
POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K051378)Medline2005-08-03
CML 1000 (K051437)Icu Medical, Inc.2005-08-03
POWDER-FREE VINYL EXAM GLOVES (K052006)Baoding Guanzhong Glove Co., Ltd.2005-08-03
SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 (K051045)Spectrx, Inc.2005-08-02
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K051935)Shijiazhuang Wonder Plastic Co., Ltd.2005-08-02
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING (K051683)Shen Wei (Usa), Inc.2005-08-01
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR (K051939)Medegen Medical Manufacturing System2005-08-01
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER (K050463)Taidoc Technology Corporation2005-07-27
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR (K051393)Ever Global Enterprise Corporation2005-07-27
NITRILE POWDERED EXAMINATION GLOVES (BLUE) (K051778)Hartalega Sdn Bhd2005-07-26
MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER (K050542)Marian Medical, Inc.2005-07-26
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 (K051194)Becton, Dickinson & CO2005-07-25
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE (K051720)Synthes (Usa)2005-07-25
MILTEX RIGID STERILIZATION CONTAINER SYSTEM (K050570)Miltex, Inc.2005-07-25
NITRILE EXAMINATION GLOVES, POWDER FREE (K051333)Shun Thai Rubber Gloves Industry Co., Ltd.2005-07-22
VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR) (K051662)Grand Work Plastic Products Co., Ltd.2005-07-22
TURBO-FLO PICC (K041849)Cook, Inc.2005-07-21
STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS) (K051329)Siam Sempermed Corp., Ltd.2005-07-19
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW) (K051723)Zibo Sinocare Plastic Products Co., Ltd.2005-07-15
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) (K051253)Baxter Healthcare Corp2005-07-15
ANGIODYNAMICS TUMESCENT INFUSION DEVICE (K051142)AngioDynamics, Inc.2005-07-13
TISSU-TRANS (K050797)Shippert Medical Technologies Corp.2005-07-13
HUBER CLEAR SAFETY INFUSION SET (K051009)Now Medical Distribution, Inc.2005-07-12
POWDERED LATEX PATIENT EXAMINATION GLOVES (K051465)P.T. Anlis Abadi Internasional2005-07-12
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES (K050968)Pt. Medisafe Technologies2005-07-12
POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR) (K051372)Platinum Glove Industries Sdn. Bhd.2005-07-07
DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR (K051498)Ever Global Enterprise Corporation2005-07-06
SYMBIOS DISPOSABLE INFUSION PUMP KIT (K051474)Symbios Medical Products, LLC2005-07-01
PENTATRASFU BLOOD TRANSFUSION SETS (K041496)Pentaferte S.P.A2005-06-30
6 FR FL POWERHOHN AND POWERLINE CATHETER (K051417)C.R. Bard, Inc.2005-06-30
SHL DISPOSABLE AUTOINJECTOR (K050434)Shl Medical, USA2005-06-24
COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET) (K051345)Glovco (M) Sdn. Bhd.2005-06-23
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET (K051499)Medegen Medical Manufacturing Services2005-06-22
OMRON MODEL 514N TYMPANIC THERMOMETER (K051233)Omron Healthcare, Inc.2005-06-21
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K051148)Zibo Sinocare Plastic Products Co., Ltd.2005-06-21
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K051154)Hebei Manful Import & Export Co., Ltd.2005-06-20
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR (K051317)Platinum Glove Industries Sdn. Bhd.2005-06-20
30 ML OR 60 ML PEDI-SYRINGE FILTER (K050805)Blood Products Specialties, LLC2005-06-20
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR) (K051318)Platinum Glove Industries Sdn. Bhd.2005-06-17
CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 (K050998)Confluent Surgical,Inc2005-06-15
6 FR DL POWERPICC CATHETER (K050931)C.R. Bard, Inc.2005-06-15
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW) (K051156)Shijiazhuang Manful Light Industrial Products Co.,2005-06-14
SUPERCATH Z3V (K050114)Togo Medikit Co., Ltd.2005-06-09
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE (K051347)Kimberly-Clark Corp.2005-06-07
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET (K051166)Gloveco, Inc.2005-06-07
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) (K050277)Hartalega Sdn Bhd2005-06-07
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K051152)Zibo Sinocare Plastic Products Co., Ltd.2005-06-03
COOL.CLICK (K050734)Bioject, Inc.2005-06-03
WAGNER STERISET STERILIZATION CONTAINER (K041096)Wagner GmbH2005-06-03
MICROPUMP MP-101 (K051252)Micrel Medical Devices S.A.2005-05-27
SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK (K051173)Spsmedical Supply Corp.2005-05-27
POWERHOHN AND POWERLINE CATHETERS (K050185)C.R. Bard, Inc.2005-05-26
ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE (K043249)Atrion Medical Products, Inc.2005-05-25
FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) (K043149)Firstline, LLC2005-05-25
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) (K050528)Spi Gloves Sdn. Bhd.2005-05-19
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY (K051079)Hospicare, Inc.2005-05-19
STRYKER DISCMONITOR (K050753)Stryker Instruments2005-05-18
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K051153)Hebei Manful Import & Export Co., Ltd.2005-05-18
DR. THEISS ALERGOL POLLEN BLOCKER CREAM (K042610)Dr. Theiss Naturwaren GmbH2005-05-16
STERRAD NX CHALLENGE PACK (K042450)Advanced Sterilization Products2005-05-12
MINILOC SAFETY INFUSION SET (K050600)Specialized Health Products, Intl.2005-05-12
ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT (K041984)Best Sanitizers, Inc.2005-05-11
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 (K050464)Ultimed, Inc.2005-05-11
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q (K051100)Microlife Intellectual Property GmbH2005-05-11
PAINPUMP2 (K043466)Stryker Instruments2005-05-10
UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES (K050116)Uniqsafe Biomeditech Co., Ltd.2005-05-09
AMIGO INSULIN PUMP (K050312)Nipro Diabetes Systems, Inc.2005-05-09
ALDAHOL III HIGH-LEVEL DISINFECTANT (K041360)Healthpoint, Ltd.2005-05-05
VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE (K040916)Vitalcare Group, Inc.2005-05-04
AMSINO I.V. START KIT (K050654)Amsino International, Inc.2005-05-02
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) (K050495)Baxter Healthcare Corp., Bioscience2005-05-02
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE (K050837)GE Healthcare2005-04-27
INFPUMP INFILTRATION PUMP (K050324)Carolina Medical, Inc.2005-04-27
STAT MEDICAL PEN NEEDLE (K042917)Emergogroup, Inc.2005-04-22
STERRAD NX STERILIZER (K042116)Advanced Sterilization Products2005-04-22
ISCIENCE SURGICAL VISCOINJECTOR (K050716)Iscience Surgical Corporation2005-04-21
BARDPORT TITANIUM PORTS (K050310)Bard Access Systems, Inc.2005-04-18
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) (K050122)Smart Glove Corp. Sdn Bhd2005-04-18
P&P SAFETY SYRINGE (K043419)Medexel Medical Mfg. Co., Ltd.2005-04-15
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS (K041495)Pentaferte S.P.A2005-04-15
MICROFLO-SAFE SCALP VEIN SET (K043328)Dks Loversan Industria Biomedica Spa2005-04-15
VEINNOVATIONS INFILTRATION SYSTEM (K050474)Veinnovations, LLC2005-04-14
MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT (K050770)Mckinley Medical, LLC2005-04-14
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA (K050532)Spi Gloves Sdn. Bhd.2005-04-14
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM (K050433)Zimmer Orthopaedic Surgical Products2005-04-13
LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE (K050765)N.S. Uni-Gloves Sdn. Bhd.2005-04-08
SPOR-TEST PA BIOLOGICAL INDICATOR KIT (K050664)Getinge USA, Inc.2005-04-07
BD POSIFLOW POSITIVE DISPLACEMENT VALVE (K050207)Becton Dickinson Infusion Therapy Systems, Inc.2005-04-07
POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) (K050598)Smart Glove Corp. Sdn Bhd2005-04-07
ICC INSULIN SAFEPRO SAFETY SYRINGE (K050134)Formosa Medical Devices, Inc.2005-04-05
DEPOTONE (K050505)Imprint Pharmaceuticals Limited2005-04-05
INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE (K050131)M.K. Meditech Co. , Ltd.2005-04-05
SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES (K050450)Zibo Blue Intco Plastic & Rubber Products Co., Ltd.2005-04-04
CIDEX OPA CONCENTRATE (K032959)Advanced Sterilization Products2005-04-04
BLOOD HAND PUMP ADMINISTRATION SET (K050115)Cardinal Health, Alaris Products2005-04-01
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN (K050467)Shen Wei (Usa), Inc.2005-03-30
SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP (K043204)Sgarlato Laboratories, Inc.2005-03-30
NOVOFINE AUTOCOVER 30G X 8MM (K050106)Novo Nordisk, Inc.2005-03-30
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C (K043600)Medtronic Minimed2005-03-29
SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES (K050455)Zibo Blue Intco Plastic & Rubber Products Co., Ltd.2005-03-29
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