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General Hospital

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

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RecordFirmDate
POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE (K080937)Gx Corporation Sdn Bhd2008-05-23
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (K073684)Sheffield Industries, Div. of Faria , Ltd.2008-05-22
SMITH & NEPHEW INSTRUMENT TRAYS (K073551)Smith & Nephew Inc., Endoscopy Div.2008-05-21
NEUTROPHASE (K081009)Novabay Pharmaceuticals2008-05-20
POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K081040)Pt.Shamrock Manufacturing Corp.2008-05-20
POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (K072300)Perusahaan Pelindung Getah (M) Sdn Bhd2008-05-16
T34L SYRINGE DRIVER (K080954)Caesarea Medical Electronics , Ltd.2008-05-16
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM (K080227)Roche Diagnostics Corp.2008-05-15
EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE (K080587)Animas Corp.2008-05-15
SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY) (K080165)Platinum Glove Industries Sdn. Bhd.2008-05-14
NOVOLET (K080665)U.S. Safety Syringes Co., Inc.2008-05-13
IV ADMINISTRATION SET (K080660)U.S. Safety Syringes Co., Inc.2008-05-13
BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR (K080750)STERIS Corporation2008-05-12
THERMOFLASH LX-26 (K080759)Jxb Co. Ltd Guangzhou (China)2008-05-12
TEMPTOUCH DERMAL THERMOMETER (K081162)Diabetica Solutions, Inc.2008-05-08
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K071999)Tangshan Hongyun Plastic Products Co., Ltd.2008-05-08
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K072084)Zibo Hongye Shangqin Plastic Rubbert Co, Ltd.2008-05-08
POWDERED VINYL PATIENT EXAMINATION GLOVES (K073192)Shijiazhuang Prosperous Plastic Co., Ltd.2008-05-02
EAR THERMOMETER, MODELS ST66 AND ST67 (K080981)Mesure Technology Co., Ltd.2008-05-02
UNIVERSAL VIAL ACCESS SPIKE (K080989)Icu Medical, Inc.2008-05-02
STD MED PRIMO PORT POLY (K080645)Std Med, Inc.2008-05-02
PROCHEM INDICATOR TAPE (K080307)Raven Laboratories2008-05-01
EMU-GRAPH EMULATOR, MODEL CI 131 (K072408)Steritec Products Mfg Co, Inc.2008-04-30
VANTAGECATH INTRAVASCULAR CATHETER (K073471)Advantage Medical Device2008-04-30
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM (K080520)Siam Sempermed Corp., Ltd.2008-04-30
AESCULAP PRIMELINE CONTAINER LTD. (K073168)Aesculap, Inc.2008-04-28
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 (K073356)Medtronic Minimed2008-04-25
LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP (K080743)Smiths Medical MD, Inc.2008-04-25
FAST1 INTRAOSSEOUS INFUSION SYSTEM (K080865)Pyng Medical Corp.2008-04-24
SAFETY INFUSION SET (K080235)Greiner Bio-One Vacuette North America2008-04-24
PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C (K080174)Cardio Med Supplies, Inc.2008-04-23
YULEX LATEX POWDER-FREE EXAM GLOVES (K063810)Yulex Corporation2008-04-18
LOW FLUID ALARM (K080704)Em-Tec GmbH2008-04-17
MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE (K072614)Matang Mfg. Sdn. Bhd.2008-04-15
IRSG I-MOVER FOR BEDS (K072598)International Retail Services Group, LLC2008-04-14
ANGIOTECH CVC (K073520)Angiotech Pharmaceuticals, Inc.2008-04-11
TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL (K071524)Tcm World, Inc.2008-04-10
SPIRUS MEDICAL SURGICAL INSTRUMENT (K080042)Spirus Medical, Inc.2008-04-03
SMART-ROD (K070584)Duoject Medical Systems, Inc.2008-04-02
AP MEDICAL SHARPS CONTAINERS 0,6-12 LT. (K071517)A.B.M. Italia S.P.A2008-04-02
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116 (K080593)Taidoc Technology Corporation2008-04-02
NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES (K072400)Sgmp Co., Ltd.2008-03-27
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS) (K072403)Sgmp Co., Ltd.2008-03-27
AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 (K072185)Airistar Technologies, LLC2008-03-27
MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE (K073705)Shandong Qiaopai Group Co., Ltd.2008-03-24
NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) (K072406)Sgmp Co., Ltd.2008-03-21
JIERUI SYRINGES AND NEEDLES (K072739)Shandong Weigao Group Medical Polymer Co., Ltd.2008-03-21
THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 (K073363)Paladin Biomedical Corporation2008-03-20
POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR (K072197)Metacure Surgical Gloves Sdn Bhd2008-03-12
DUAL CHAMBER TPN CONTAINER (K073538)B.Braun Medical, Inc.2008-03-12
JET PORT PLUS HP CATHETER SYSTEM (K072481)Pfm Medical, Inc.2008-03-07
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR (K072144)Smiths Medical MD, Inc.2008-03-07
COMPACT AUTO-SAFETY INJECTOR (CASI) (K073476)Medical House (Asi) Limited2008-03-07
BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE (K073299)Betel Care Sdn. Bhd.2008-03-05
VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) (K080066)Gx Corporation Sdn Bhd2008-03-05
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR (K073339)Fenwal, Inc.2008-03-03
SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE (K072802)Ultrawin Sdn Bhd2008-02-29
INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS (K072211)Intuitive Surgical, Inc.2008-02-28
MEDICAL GLOVE SERIES (K072145)Zhanjiang Jiali Glove Products Co., Ltd.2008-02-26
NEOMED SINGLE LUMEN UMBILICAL CATHETER (K073596)Neomed, Inc.2008-02-22
VINYL EXAMINATION GLOVE, POWDERED (K072223)Pinnacle Co., Ltd.2008-02-21
ALPHA INFUSION PUMP, MODEL A200, A450 (K071532)Advanced Infusion, Inc.2008-02-19
VINYL EXAMINATION GLOVE POWDER FREE (K072227)Pinnacle Co., Ltd.2008-02-15
CLAVE STOPCOCK (K080077)Icu Medical, Inc.2008-02-13
FAST1 INTRAOSSEOUS INFUSION SYSTEM (K072487)Pyng Medical Corp.2008-02-13
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) (K072955)Smiths Medical MD, Inc.2008-02-13
INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 (K071307)Inviro Medical Devices, Inc.2008-02-12
MILTEX RIGID CONTAINER SYSTEMS (K072563)Miltex, Inc.2008-02-12
VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM (K073241)Vascular Pathways2008-02-08
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE (K073188)Smiths Medical Asd, Inc.2008-02-08
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) (K072228)Pinnacle Co., Ltd.2008-02-08
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041 (K073366)Shenzhen Dongdixin Technology Co., Ltd.2008-02-08
GELSPRAY WOUND DRESSING (K073663)Biocure, Inc.2008-01-30
KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR (K073257)Kawasumi Laboratories, Inc.2008-01-25
VERIFY CHALLENGE PACKS - VERSION 2 (K073683)STERIS Corporation2008-01-25
SAFESTEP MAX POWER-INJECTABLE INFUSION SET (K073050)Specialized Health Products International, Inc.2008-01-25
CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1 (K072635)Ningbo Huahui Medical Instruments Co., Ltd.2008-01-17
NEEDLE-TRAP/NEEDLE SAFETY LABEL (K073206)Schreiner Medipharm2008-01-16
PRESSURE INJECTABLE PICC (K073451)Arrow International, Inc.2008-01-15
CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008 (K072790)Confluent Surgical,Inc2008-01-11
AVIATOR INSULIN PUMP (K071788)Abbott Diabetes Care, Inc.2008-01-11
ALARIS SYSTEM WITH MMS, MODEL 8XXX (K072105)Cardinal Health 303,Inc.2007-12-28
SELF SEAL STERILIZATION POUCH (K071886)Shanghai Jianzhong Medical Packaging Co., Ltd.2007-12-27
CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS) (K072518)Crs Medical Diagnostics, Inc.2007-12-20
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K073193)Shijiazhuang Prosperous Plastic Co., Ltd.2007-12-20
BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G (K073127)Shandong Weigao Group Medical Polymer Co., Ltd.2007-12-20
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 (K072466)Scican , Ltd.2007-12-19
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER (K073423)C.R. Bard, Inc.2007-12-19
STERRAD 100NX TEST PACK (K071537)Advanced Sterilization Products2007-12-18
SMARTSITE STOPCOCK (K071400)Cardinal Health, Alaris Products2007-12-14
PLASMAIR, MODEL T2006 (K070722)Airinspace B.V.2007-12-14
AMIGO INSULIN PUMP (K071613)Nipro Diabetes Systems, Inc.2007-12-14
POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS (K072657)Smiths Medical MD, Inc.2007-12-14
PATIENT SAFE SYRINGE (K072654)Retractable Technologies, Inc.2007-12-14
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR (K072377)Xuzhou Full Sun Medical Products , Ltd.2007-12-14
SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM (K072511)Medimop Medical Projects, Ltd.2007-12-13
SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET (K072375)AngioDynamics, Inc.2007-12-13
VIAL2BAG (K072759)Medimop Medical Projects, Ltd.2007-12-13
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) (K072625)Cook, Inc.2007-12-13
DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR (K071122)Xuzhou Full Sun Medical Products , Ltd.2007-12-12
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