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General Hospital

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

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RecordFirmDate
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102431)Tangshan Fuqiang Glove Co., Ltd.2010-10-04
POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K101828)Gx Corporation Sdn Bhd2010-10-04
3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM (K101528)3M Company2010-10-01
AMSINO I.V. ADMINISTRATION AND EXTENSION SETS (K101958)Amsino International, Inc.2010-09-29
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100421)Tangshan Yonkshun Glove, Co., Ltd.2010-09-27
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102098)Hong DI Plastic Products Co., Ltd.2010-09-27
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM (K102462)STERIS Corporation2010-09-21
SHAPE TO FIT COMPRESSION WEAR (K101906)Tsung Hau Technology Co., Ltd.2010-09-17
SMITH & NEPHEW INSTRUMENT TRAYS (K092551)Smith & Nephew Inc., Endoscopy Div.2010-09-14
NUGARD NITILE GREY COLOR (K102230)Terang Nusa Sdn Bhd2010-09-10
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS (K102032)Kimberly-Clark Corp.2010-09-08
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR (K101646)Sgmp Co., Ltd.2010-09-08
STERIGAGE MODEL 1243RA, 1243RB, 1243RE (K101249)3M Company2010-09-08
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE (K101630)Pt. Smartglove Indonesia2010-09-07
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE (K101799)Wear Safe (Malaysia) Sdn. Bhd.2010-09-03
SHARPS CONTAINER (K101567)Cixi Leinuo Plastic Co., Ltd.2010-09-02
NMI IC (K101326)Navilyst Medical, Inc.2010-09-02
EASY TOUCH (K102178)Mhc Medical Products2010-09-02
FASTX STERNAL INTRAOSSEOUS DEVICE (K100124)Pyng Medical Corp.2010-08-31
1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1 (K100998)Unilife Medical Solutions Limited2010-08-30
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 (K100635)Arrow Intl., Inc.2010-08-27
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 (K100622)Belimed Sauter AG2010-08-27
ACCU-CHEK ULTRFLEX INFUSION SET (K101196)Roche Diagnostics Corp.2010-08-27
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF (K101645)Latexx Manufacturing Sdn.Bhd.2010-08-26
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K101358)Hebei Handform Plastic Products Co., Ltd.2010-08-24
LUMENVU CATHETER GUIDANCE SYSTEM (K093510)Sonosite,Inc.2010-08-23
ZIRCONIA SYRINGE NEEDLE (K093043)Kuo Tai Hospital Managements & Consultant Co., Ltd.2010-08-20
INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) (K101359)Inviro Medical Devices, Inc.2010-08-20
SYNERGY CT PICC (K101329)Health Line International Corporation2010-08-19
HUMAPEN LUXURA HD (K100988)Eli Lilly and Company2010-08-17
POWDER - FREE PATIENT EXAMINATION GLOVES (K101565)Zibio Yingjie Medical Products Co., Ltd.2010-08-17
ABREU, MODEL 700 (K100843)Brain Tunnelgenix Technologies Corp2010-08-17
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE (K100975)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-08-17
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE (K100978)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-08-12
ORLOCATE SYSTEM MODEL ORL 100 (K100551)Haldor Advanced Technologies, Ltd.2010-08-12
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE (K100977)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-08-12
HOSPIRA INFUSION BLOOD SETS (K101677)Hospira, Inc.2010-08-11
VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY (K100887)Tag Medical Products2010-08-09
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE (K101595)Better Care Plastic Technology Cp., Ltd.2010-08-06
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100963)Hebei Shenzichen Plastic & Rubber Products Co., LT2010-08-06
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE (K101747)Kaz USA, Inc (A Subsidiaryof Kaz Inc)2010-08-04
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, (K101180)Smiths Medical MD, Inc.2010-08-03
1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 (K092892)I-Ming Sanitary Materials Co., Ltd.2010-08-03
DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN (K101387)Fudakang Industries Co., Ltd.2010-08-03
MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES (K101653)Miltex, Inc.2010-08-02
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM (K101409)STERIS Corporation2010-08-02
INTRAVSCULAR ADMINISTRATION SET (K100946)Terumo Europe N.V.2010-08-02
IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY (K093489)Rymed Technologies, Inc.2010-07-29
JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 (K101322)Joinsoon Electronics Mfg Co, Ltd.2010-07-28
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K101663)Hebei Excellent Plastic Co., Ltd.2010-07-27
POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO (K101026)Vidacare Corporation2010-07-27
AESCULAP STERILCONTAINER S (K093493)Aesculap, Inc.2010-07-27
POWDERED VINYL PATIENT EXAMINATION GLOVES (K101664)Hebei Excellent Plastic Co., Ltd.2010-07-27
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 (K100488)Shenzhen Dongdixin Technology Co., Ltd.2010-07-22
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 (K100640)B.Braun Medical, Inc.2010-07-22
GIRAFFE AND PANDA WARMERS (K101804)Ohmeda Medical, A Division of Datex-Ohmeda, Inc.2010-07-21
ECT DIGITAL THERMOMETER (K101043)Changshan Estar Electronics Co., Ltd.2010-07-21
GIRAFFE INCUBATOR (K101778)Ohmeda Medical2010-07-21
JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001 (K101232)Joinsoon Electronics Mfg Co, Ltd.2010-07-21
GIRAFFE OMNIBED (K101788)Ohmeda Medical2010-07-21
KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- (K101596)Kimberly-Clark2010-07-21
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K101840)Shijiazhuang Sail Plastic Co., Ltd.2010-07-16
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K101841)Shijiazhuang Sail Plastic Co., Ltd.2010-07-16
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100964)Hebei Shenzichen Plastic & Rubber Products Co., LT2010-07-16
RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) (K100611)Riverstone Resources Sdn Bhd2010-07-16
RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (K100603)Riverstone Resources Sdn Bhd2010-07-16
POWDERED VINYL PATIENT EXAMINATION GLOVES (K101343)Shijiazhuang Star Plastic Co., Ltd.2010-07-16
EVGUIDE TIP LOCATION SYSTEM (K093775)Romedex International Srl2010-07-15
VIVATRAK (K101109)Wireless Medcare, LLC2010-07-15
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 (K100066)Welldoc, Inc.2010-07-15
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432)Medtronic Minimed2010-07-09
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL (K100907)Siam Sempermed Corp., Ltd.2010-07-09
CLAVE NEUTRON (K100434)Icu Medical, Inc.2010-07-09
SECURACATH UNIVERSAL (K092306)Interrad Medical, Inc.2010-07-09
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K100057)Tangshan Kangyuan Glove Co., Ltd.2010-07-08
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 (K100705)Zyno Medical, LLC2010-07-08
NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED (K101736)Shenzhen Everbest Machinery Industry Co., Ltd.2010-07-06
ACTIPROTECT UC N95 RESPIRATOR (K093189)Glaxosmithkline Consumer Healthcare2010-07-02
NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE (K100979)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-07-02
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) (K101293)Pt. Smartglove Indonesia2010-07-01
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK) (K101132)Hong DI Plastic Products Co., Ltd.2010-07-01
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) (K100059)Tangshan Zhongpu Plastic Products Co., Ltd.2010-07-01
NEV'S INK AUTOCLAVE TAPES (K101580)Nev'S Ink, Inc.2010-07-01
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK) (K101135)Hongze Plastic Technology Co., Ltd.2010-07-01
RII INFRARED EAR THERMOMETER, MODEL: TH60N (K101253)Radiant Innovation, Inc.2010-06-29
NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES (K093516)Summit Glove, Inc.2010-06-29
NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE (K093517)Summit Glove, Inc.2010-06-29
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 (K100947)Calibra Medical, Inc.2010-06-28
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN (K100694)Tekmedic (M) Sdn Bhd2010-06-25
MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX (K100665)Needle Tech Products, Inc.2010-06-24
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C (K100798)Medrad, Inc.2010-06-23
POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K101137)Hongze Plastic Technology Co., Ltd.2010-06-22
DUAL LUER LOCK CAP, MODEL 2C6250 (K101385)Baxter Healthcare Corp2010-06-22
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES (K092874)Quality Gallant Sdn. Bhd.2010-06-22
PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 (K100495)Philips Electronics UK Limited2010-06-22
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) (K093335)La Glove (M) Sdn. Bhd.2010-06-18
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') (K093109)Novo Nordisk, Inc.2010-06-18
HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 (K092938)App Pharmaceuticals, LLC2010-06-18
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K101362)Hebei Handform Plastic Products Co., Ltd.2010-06-17
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS (K101017)AngioDynamics, Inc.2010-06-17
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