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General Hospital

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

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RecordFirmDate
SMART-WELL EZTEST INCUBATOR (K091950)Sgm Biotech, Inc.2010-01-15
DISPOSABLE HYPODERMIC NEEDLE (K092831)Feel Tech2010-01-14
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES (K092447)Hangzhou Hua'An Medical & Health Instruments Co.,2010-01-07
SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 (K092346)Serim Research Corp.2010-01-07
EXEL I.V. EXTENSION SET (K092172)Exelint Intl. Co.2010-01-04
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION (K092906)STERIS Corporation2009-12-30
STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K091851)Gx Corporation Sdn Bhd2009-12-28
LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA (K090959)D'Antonio Consultants International, Inc. (Dci)2009-12-24
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093439)Tangshan Pufa Plastic Products Co., Ltd.2009-12-22
AMSCO WARMING CABINET (K092823)STERIS Corporation2009-12-18
SMARTWAND-DTX (K093557)Clearcount Medical Solutions2009-12-18
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 (K090921)Beiersdorf, Inc.2009-12-18
DYNAREX STERILE LUBRICATING JELLY (K092488)Dynarex Corporation2009-12-18
DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES (K092557)Harvard Medical Devices , Ltd.2009-12-17
FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER (K093252)Footprint Medical, Inc.2009-12-17
SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX (K093546)Togo Medikit Co., Ltd.2009-12-17
LOUSEBUSTER (K093144)Larada Sciences2009-12-16
GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS (K092682)Gyrus Acmi, Inc.2009-12-11
DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) (K093332)Delphi Medical Systems2009-12-09
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092966)Jin Zhou Chang Hao Plastic Products Co., Ltd.2009-12-08
INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, (K092782)Carmel Pharma Ab.2009-12-07
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092956)Shandong Aobo Medical Co, Ltd.2009-12-04
3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK (K093199)3M Company2009-12-04
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (K093570)Jiangsu Jaysun Glove Co., Ltd.2009-12-04
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K092820)Shijiazhuang Fuhao Plastic Products Co., Ltd.2009-12-03
TSO3 OZONE STERILIZER, MODEL 125L (K090636)Tso3, Inc.2009-12-02
AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES (K092958)Avita Corporation2009-12-02
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) (K093375)Koon Seng Sdn Bhd2009-12-02
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093277)Tangshan Green Healthcare Co., Ltd.2009-11-30
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093272)Tangshan Huamei Healthcare Co., Ltd.2009-11-30
POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES (K092160)Comfort Rubber Gloves Ind. Sdn. Bhd.2009-11-27
AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152 (K092959)Avita Corporation2009-11-27
PRO-LINE CT (BASIC TRAY) MODEL MR28036101 (K093309)Medcomp ( Medical Components)2009-11-24
POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED (K091965)Platinum Glove Industries Sdn. Bhd.2009-11-24
NMI PICC II (K093366)Navilyst Medical, Inc.2009-11-24
LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) (K092499)La Glove (M) Sdn. Bhd.2009-11-20
LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) (K092498)La Glove (M) Sdn. Bhd.2009-11-20
PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 (K092040)R4 Vascular, Inc.2009-11-18
VPS CATHETER (K091924)Vasonova, Inc.2009-11-18
NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 (K092246)Nipro Medical Corporation2009-11-12
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093276)Tangshan Kangyuan Glove Co., Ltd.2009-11-04
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (K092313)B.Braun Medical, Inc.2009-11-04
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 (K092490)STERIS Corporation2009-11-04
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE (K092072)Gx Corporation Sdn Bhd2009-11-04
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093270)Tangshan Excellence Glove Co., Ltd.2009-11-04
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 (K092167)Kimberly-Clark Corp.2009-11-02
POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K091643)Gx Corporation Sdn Bhd2009-11-02
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K092790)Zibo Boxiang Plastic & Rubber Co., Ltd.2009-11-02
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE (K092318)Baxter Healthcare Corporation2009-10-30
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET (K091441)Synergetics, Inc.2009-10-30
SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2 (K091736)Daniels Corporation Pty, Inc.2009-10-30
ACACIA PISTON SYRINGE (K092986)Acacia, Inc.2009-10-27
VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL (K091174)STERIS Corporation2009-10-27
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK) (K092301)Bettercare Plastic Products Co., Ltd.2009-10-22
EQUALSHIELD LUER LOCK CONNECTOR PAIR (K091389)Plastmed, Ltd.2009-10-22
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O (K092492)Wear Safe (Malaysia) Sdn. Bhd.2009-10-21
POWDER FREE EXAMINATION GLOVE (K092296)Bettercare Plastic Products Co., Ltd.2009-10-21
VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR (K092294)Bettercare Plastic Products Co., Ltd.2009-10-21
RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR (K082756)Raven Biological Laboratories, Inc.2009-10-21
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) (K092411)Shen Wei (Usa), Inc.2009-10-21
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK (K092034)Pt. Smartglove Indonesia2009-10-19
PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL (K091471)Cartagloves S.A.2009-10-15
EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO (K091140)Vidacare Corporation2009-10-14
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC (K091709)Edwards Lifesciences, LLC2009-10-13
DISPOSABLE TPE INFUSION SET (K090459)Shan Dong Wei Gao Group Medical Polymer Products2009-10-13
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092109)Zhangjiangang All Fine Rubber-Plastic Products Co.2009-10-09
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS (K090650)Spsmedical Supply Corp.2009-10-09
REMOTE INFRARED THERMOMETER, MODEL RC002 (K090361)Rycom Electron Technology Limited2009-10-08
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092516)Zi BO Yuxiang Gloves Co., Ltd.2009-10-07
SUPER-FINE PEN NEEDLE (K092016)Stat Medical Devices, Inc.2009-10-02
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN (K090568)Medline Industries, Inc.2009-10-02
MICROFUSE DUAL RATE INFUSER (K091386)Numia Medical Technology, LLC2009-10-02
AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET (K090117)Autosafe-Reflex, Inc.2009-09-29
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER (K091214)Footprint Medical2009-09-25
SNM FIRMGRIP (K092629)Flexicath , Ltd.2009-09-25
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K082648)Tangshan Dar Plastic & Rubber Products Co. , Ltd.2009-09-25
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K092415)Shijiazhuang Elegance Plastic Product2009-09-25
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN (K091213)Footprint Medical2009-09-25
BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 (K090339)Belimed Sauter AG2009-09-23
POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES (K091942)Zibo Intco Medical Products Co., Ltd.2009-09-21
MICRO-TOUCH NITRA FREE (K092327)Ansell Healthcare Products, LLC2009-09-21
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES (K092100)Tangshan Hongxing Plastic Products Co., Ltd.2009-09-18
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES (K092000)Shangdong Zibo Shanchuan Medical Instruments Co.2009-09-18
AMSCO EVOLUTION MEDIUM STEAM STERILIZER (K091731)STERIS Corporation2009-09-17
POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) (K092200)Gx Corporation Sdn Bhd2009-09-16
PRO-PICC CT (K092347)Medcomp2009-09-16
POWDERED VINYL PATIENT EXAMINATION GLOVES (K092416)Shijiazhuang Elegance Plastic Product2009-09-16
PRO-PICC (K091953)Medcomp2009-09-16
FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C (K091488)Footprint Medical2009-09-14
1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES (K092430)Inviro Medical Devices, Inc.2009-09-04
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS (K091652)Hartalega Sdn Bhd2009-09-04
INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES (K092413)Inviro Medical Devices, Inc.2009-09-04
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 (K091685)Kimberly-Clark Corp.2009-09-03
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 (K091676)Omron Healthcare, Inc.2009-09-01
VERIFY SCBI 275F 3-10 (K083665)STERIS Corporation2009-09-01
ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 (K090156)Wcm Waste & Compliance Management, Inc.2009-09-01
XTRACT SYRINGE KEYS (K091200)Xtract Solutions, LLC2009-08-21
TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE (K090783)Tuttnauer U.S.A Co, Ltd.2009-08-20
KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS (K090818)KARL STORZ Endoscopy-America, Inc.2009-08-18
TISSU TRANS HARVEST TUBING (K092022)Shippert Medical Technologies Corp.2009-08-17
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