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General Hospital

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

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RecordFirmDate
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) (K111297)Premier Medical Gloves Factory2011-06-16
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (K111459)Jiangsu Alfa Glove Co., Ltd.2011-06-16
POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES (K110297)Comfort Rubber Gloves Industries Sdn. Bhd.2011-06-15
ADDITIVE CAP (K111217)Baxter Healthcare Corp2011-06-14
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) (K111244)Cook, Inc.2011-06-14
POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR (K110247)Jiangsu Dongling Plastic & Rubber Co., Ltd.2011-06-10
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR (K110248)Jiangsu Dongling Plastic & Rubber Co., Ltd.2011-06-10
DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE (K103736)Dmc Medical, Ltd.2011-06-10
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K110969)Ppp Medical and Safety Products Company Limited2011-06-10
SAFEPORT MANIFOLD (TM) (OR STOPCOCK) (K111016)Elcam Medical Acal2011-06-09
K-PACK II NEEDLE- 27G & 30G THIN WALL (K110850)Terumo Europe N.V.2011-06-09
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE (K110527)Terumo Europe N.V.2011-06-06
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS (K103210)Advanced Sterilization Products2011-06-06
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (K110972)Ppp Medical and Safety Products Company Limited2011-06-06
BEHIND EAR GENTLE TOUCH THERMOMETER (K103839)Kaz, Inc.2011-06-06
BLUE POWDERFREE NITRILE EXAMINATION GLOVE (K102623)Pt. Medisafe Technologies2011-06-06
AMSCO WARMING CABINET (K110769)STERIS Corporation2011-06-03
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) (K100895)Dipped Products Limited2011-05-27
INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A (K102935)Kingtech Enterprise, Ltd.2011-05-27
CLASSIX CHEMICAL STERILIZATION INDICATOR (K102894)Propper Mfg. Co., Inc.2011-05-25
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K110155)Tangshan Xiangrui Plastic Products Co., Ltd.2011-05-23
RMS SUBCUTANEOUS NEEDLE SET (K102512)Repro-Med Systems, Inc.2011-05-20
HYPOTHERMX INTRAVENOUS FLUID WARMER (K103801)Emit Corporation2011-05-20
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT (K102970)Gyrus Acmi, Inc.2011-05-20
BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA (K102328)Shandong Weigao Group Medical Polymer Co., Ltd.2011-05-13
COTRONIC DIGITAL THERMOMETER (K103407)Cotronic Manufacturing2011-05-13
BD SINGLE USE, HYPODERMIC SYRINGE (K110771)Becton, Dickinson and Company2011-05-13
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM (K103589)Natus Medical Incorporated2011-05-13
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K110146)Tangshan Kaiyue Glove Co., Ltd.2011-05-13
POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG (K110102)Preventive Care, Inc.2011-05-13
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX (K103525)International Biomedical, Ltd.2011-05-11
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX (K103523)International Biomedical, Ltd.2011-05-11
PEARL DIABETES MANAGEMENT SYSTEM (K100567)M2 Group Holdings, Inc.2011-05-10
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED) (K110314)True Glove Factory2011-05-10
DYNACOR LUBRICATION GEL (K103718)Medline Industries, Inc.2011-05-10
INDISTRIP GREEN (K110369)Indilab, Inc.2011-05-06
REUSABLE TEST PACK FOR DANA EMULATING INDICATORS (K110253)Dana Products, Inc.2011-04-29
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K103196)Changda Plastic Product Co., Ltd.2011-04-29
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102152)Hebei Tengda Plastic Co., Ltd.2011-04-28
BD PEN NEEDLE (K110105)Becton, Dickinson and Company (BD)2011-04-28
POWDERED VINYL PATIENT EXAMINATION GLOVES (K102151)Hebei Tengda Plastic Co., Ltd.2011-04-27
LIGHTY DD INFUSION SET (K110282)Medx-Set, Ltd.2011-04-27
DISPOSABLE INSULIN SYRINGE (K110421)Wenzhou Wuzhou Import & Export Co., Ltd.2011-04-26
PROTECTIVE RESTRAINT (K110377)Medi-Tech Intl. Corp.2011-04-25
RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR (K102902)Rubbercare Protection Products Sdn Bhd2011-04-22
POSEY BED (K103817)J. T. Posey Co.2011-04-22
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL (K103770)Syntex Healthcare Products Co., Ltd.2011-04-21
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM (K103602)Medline Industries, Inc.2011-04-21
CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE (K110112)Rongshan LI2011-04-20
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K110338)Zibo Yuechuan Plastic Products Co., Ltd.2011-04-19
3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER (K103277)3M Company-3M Health Care2011-04-19
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K110219)Wealth on (Jiangsu) Co., Ltd.2011-04-19
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX (K103524)International Biomedical, Ltd.2011-04-15
NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K110921)Cardinal Health, Inc.2011-04-15
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS (K110152)Spsmedical Supply Corp.2011-04-15
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX (K103527)International Biomedical, Ltd.2011-04-15
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K102085)Shijiazhuang Glory Plastic Co., Ltd.2011-04-14
EVA TPN BAG (K101412)Valmed S.R.L.2011-04-13
INFUSION ADAPTER C100 (K110023)Carmel Pharma Ab.2011-04-12
PROPEP DELIVERY DEVICE (K103200)Rhythmlink International, LLC2011-04-12
DISPOSABLE BLLOD COLLECTION NEEDLE (K103587)Weihai Hongyu Medical Devices Co., Ltd.2011-04-06
MICROLIFE DIGITAL UNDERARM THERMOMETER (K103680)Microlife Intellectual Property GmbH2011-04-06
SHARPS CONTAINER (K110262)Noble Marketing2011-04-05
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K110185)Tangshan Baojie Glove Co., Ltd.2011-04-04
DIGITAL FOREHEAD THERMOMETER (K103617)K-Jump Health Co., Ltd.2011-04-04
STERRAD SEALSURE CHEMICAL INDICATOR TAPE (K103219)Advanced Sterilization Products2011-04-01
STERRAD CHEMICAL INDICATOR STRIP (K103218)Advanced Sterilization Products2011-04-01
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) (K103670)Innovative Gloves Co;, Ltd.2011-03-31
BILI-THERAPY SPOT TYPE (K103828)Atom Medical Corporation2011-03-29
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, (K103551)Baxter Healthcare Corp2011-03-25
MEDLINE RETRACTABLE SAFETY SYRINGE (K101560)Medline Industries, Inc.2011-03-25
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM (K103650)Oon Corp. Resources2011-03-23
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE (K103661)Rubbercare Protection Products Sdn Bhd2011-03-23
SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE (K110224)Weifang Beihai Color Printing Packagging Co., Ltd.2011-03-18
PATIENT EXAMINATION GLOVES (K102846)Thai Hua Holding Co., Ltd.2011-03-17
GETINGE 400HC/500HC SERIES STEAM STERILIZER (K103504)Getinge Sourcing, LLC2011-03-16
SINGLE CANNULA EXTENDED APPLICATOR (K102563)Micromedics, Inc.2011-03-15
ALLERGEAZE R CLEAR (K103409)Smartpractice2011-03-15
BELIMED STEAM STERILIZER MST-V (K103841)Sauter AG2011-03-15
VERIFY 270FP CHALLENGE PACK (K103053)STERIS Corporation2011-03-10
STERRAD 100NX STERILIZER EXPRESS CYCLE (K092622)Advanced Sterilization Products2011-03-04
AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES (K102554)Avita Corporation2011-03-03
TROPHON CHEMICAL INDICATOR (K103126)Nanosonics Limited2011-03-03
NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES (K101820)Yty Industry (Manjung) Sdn Bhd2011-03-03
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM (K110456)Pharmajet, Inc.2011-03-02
MULTIPLE NAME (K103337)Ideal Quality Sdn., Bhd.2011-02-25
STERRAAD 100NX EXPRESS CYCLE TEST PACK (K092755)Advanced Sterilization Products2011-02-25
VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE) (K103772)Advanced Medical Devices Factory2011-02-25
STERRAD CYCLESURE BIOLOGICAL INDICATOR (K103222)Advanced Sterilization Products2011-02-25
NON-CONTACT INFRARED THERMOMETER (K102947)K-Jump Health Co., Ltd.2011-02-25
PATIENT SAFE LUER CAP (K101708)Retractable Technologies, Inc.2011-02-24
INDISCAL DIGITAL MANOMETER (K102192)Baylis Medical Co., Inc.2011-02-23
V-GO INSULIN DELIVERY SYSTEM (K103825)Valeritas, Inc.2011-02-23
VTS1000 (K101838)Vuetek Scientific, LLC2011-02-18
SAFE'N'SOUND PASSIVE DELIVERY SYSTEM (K101233)Rexam Pharma2011-02-18
PATIENT EXAMINATION GLOES (K102840)Thai Hua Holding Co., Ltd.2011-02-18
STERILIZATION MATS (K103226)STERIS Corporation2011-02-18
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES (K103321)Dana Products, Inc.2011-02-16
SMART READ BIOLOGICAL TEST PACK (K103000)Steritec Products Mfg Co, Inc.2011-02-11
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 (K101270)Excelsior Medical Corp.2011-02-10
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