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General Hospital

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

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RecordFirmDate
WHITE VINYL EXAM GLOVES POWDER FREE (K140322)Shandong Dawei Medical Products Co., Ltd.2014-06-12
FEIYUE (K140242)Feiyue Glove Co., Ltd.2014-06-12
JIAWANG (K140239)Jiawang Glove Co., Ltd.2014-06-12
EWNL SAFETY SYRINGE WITH NEEDLE (K132557)Jiamei-Un Co., Ltd.2014-06-03
POWDER FREE POLYETHYLENE EXAMINATION GLOVES (K133478)Shijiazhuang Hongzan Plastic Technology Co.,Ltd2014-06-02
SURFLASH SAFETY I.V. CATHETER (K141138)Kofu Factory of Terumo Corp.2014-05-30
NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F (K133123)Yty Industry (Manjung) Sdn Bhd2014-05-30
MEDI PEN NEEDLE (K131954)Shanghai Carelife International Trading Co. , Ltd.2014-05-29
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M (K133953)Hartalega Sdn Bhd2014-05-28
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN (K133956)Hartalega Sdn Bhd2014-05-28
NEXUS NIS-6P LUER ACTIVATED DEVICE (K133351)Nexus Medical, LLC2014-05-22
SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE (K132681)Sol-Millennium Medical, Inc.2014-05-22
NOVOFINE PLUS 32G 4 MM (K133738)Novo Nordisk, Inc.2014-05-21
NO TOUCH+FOREHEAD NTF 3000 THERMOMETER (K134043)Kaz USA, Inc (A Subsidiaryof Kaz Inc)2014-05-21
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM (K140169)Cook Incorporated2014-05-21
NAMSA CHEMICAL PROCESS (K132291)North American Science Assoc., Inc.2014-05-20
INFUSET FLOW CONTROL EXTENSION SET (K140133)Emed Technologies Corporation2014-05-15
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR (K140591)Becton, Dickinson & CO2014-05-14
CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT (K140568)Facet Technologies, LLC2014-05-13
EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) (K132899)Equashield Medical , Ltd.2014-05-13
TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE (K131531)Anhui Tiankang Medical Products Co., Ltd.2014-05-12
SUPERCATH5 (K140419)Togo Medikit Co., Ltd.2014-05-12
PIXEL 3 SYSTEM (DEN130015)Gauss Surgical, Inc.,2014-05-09
CARESITE LUER ACCESS DEVICE (K140311)B.Braun Medical, Inc.2014-05-07
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY (K133801)Baxter Healthcare Corporation2014-05-07
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K122656)Shandong Yifan Plastic Products Co., Ltd.2014-05-06
AIRVIEW MINI OWIE DICK TEST PACK (K133204)Crosstex International2014-05-05
SHARPS CONTAINER (K132476)Grp & Associates2014-05-02
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K132637)Zibo Intco Medical Products Co., Ltd.2014-05-01
FLUID LEVEL MONITOR (K133870)Coleman Laboratories2014-04-24
MEDSOURCE SELECTABLE IV SET (K140442)Medsource International, LLC2014-04-22
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR (K140831)Care Fusion2014-04-15
NAMIC RCS SYRINGE (K140194)Navilyst Medical, Inc.2014-04-14
POWDERED VINYL EXAMINATION GLOVES (K122176)Shu Tong Xinghua Co., Ltd.2014-04-11
POWDER FREE VINYL EXAMINATION GLOVES (K122377)Shu Tong Xinghua Co., Ltd.2014-04-11
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K133949)Top Calibre Sdn Bhd2014-04-08
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET (K140131)Emed Technologies Corporation2014-04-03
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET (K140402)Medsource International, LLC2014-04-03
STERRAD 50/100S/200 TEST PACK (K130263)Advanced Sterilization Products2014-03-28
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC (K133116)Conmed Corporation2014-03-28
SINGLE USE STERILE SYRINGE WITH NEEDLE (K133493)Jiangxi Kelun Medical Devices Manufacturing Co.,Lt2014-03-27
T:SLIM INSULIN DELIVERY SYSTEM (K133593)Tandem Diabetes Care, Inc.2014-03-24
APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET (K132011)Aea Srl2014-03-21
CAIR DRIVE, NEUTRACLEAR (K133073)Cair Lgl2014-03-20
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) (K133894)Terumo Europe N.V.2014-03-18
ELECTRONIC THERMOMETER (K131210)Shenzhen Pump Medical System Co., Ltd.2014-03-18
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) (K140345)C.R. Bard, Inc.2014-03-14
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (K133015)Summit Medical, Inc.2014-03-13
E-Z LINK (K133097)Duoject Medical Systems, Inc.2014-03-13
BWCSH-1 SHARPS CONTAINER (K131708)Bradford Wright Companies, Inc.2014-03-10
NMI PICC IV (K140266)Navilyst Medical, Inc.2014-03-05
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130751)Cabin Plastic Co., Ltd.2014-03-05
AIRPURGE (DEN080009)Anesthesia Safety Products, LLC2014-03-04
U&U STERILE PISTON SYRINGE WITHOUT NEEDLE (K132553)U&U Medical Technology Co, Ltd.2014-02-27
U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL (K123162)U&U Medical Technology Co, Ltd.2014-02-26
INSULIN PEN NEEDLE (K133058)Wenzhou Wuzhou Import & Export Co., Ltd.2014-02-25
INSULIN PEN NEEDLE (K133059)Wenzhou Beipu Science & Technology Co., Ltd.2014-02-25
FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER (K132457)Biocare Asia Corporation , Ltd.2014-02-21
JMS SYRINGE (K132321)JMS North America Corporation2014-02-20
INFANT PHOTOTHERAPY BILITRON SKY 5006 (K131196)Fanem Lda2014-02-20
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130800)Kaixuan Plastic Co., Ltd.2014-02-18
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130809)Jewel Plastic Co., Ltd.2014-02-18
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K130891)Friend Plastic Co., Ltd.2014-02-18
POWERPORT IMPLANTABLE PORT (K133335)C.R. Bard, Inc.2014-02-14
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE (K140136)Nipro Medical Corporation2014-02-14
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K131033)Decent Plastic Co., Ltd.2014-02-12
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; (K131154)Zevex, Inc.2014-02-12
POWDER FREE LATEX EXAMINATION GLOVES (K123537)Qube Medical Product Sdn Bhd2014-02-12
DANA REUSABLE TEST PACK (K133267)Dana Products, Inc.2014-02-11
EZ-IO INTRAOSSEOUS INFUSION SYSTEM (K132583)Vidacare Corporation2014-02-11
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) (K133263)Proteus Digital Health, Inc.2014-02-07
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130807)Hope Plastic Co., Ltd.2014-02-07
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K131341)Shijiazhuang Winful Plastic Co., Ltd.2014-02-06
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130890)Air Plastic Co., Ltd.2014-02-06
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) (K133867)Terumo Europe N.V.2014-02-05
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130582)Heze City Green Food Co., Ltd.2014-02-04
DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER (K132140)Duteck Industrial Co., Ltd.2014-02-04
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (K131249)I-Flow, LLC2014-02-03
MEDLINE SHARPS CONTAINER (K132767)Medline Industries, Inc.2014-02-03
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K132221)Shandong Haoyu Medical Products Co., Ltd.2014-01-31
ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER (K132792)Daniels Sharpsmart, Inc.2014-01-31
MEDSOURCE IV SAFETY CATHETER (K131555)Medsource International, LLC2014-01-31
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K131344)Shijiazhuang Wally Plastics Co., Ltd.2014-01-30
ADD-VANTAGE ADDAPTOR (K133602)Hospira, Inc.2014-01-24
ZYNO MEDICAL ADMINISTRATION SET (K132841)Zyno Medical, LLC2014-01-23
CAREFINE PEN NEEDLE (K133100)Facet Technologies2014-01-23
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130732)Aide Plastic Co., Ltd.2014-01-16
POWERGLIDE MIDLINE CATHETER (K133856)C.R. Bard, Inc.2014-01-16
MIXING SYRINGE SYSTEM (K133021)Zimmer Knee Creations, Inc.2014-01-13
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE (K132880)Medical Components, Inc.2014-01-08
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K131832)Shandong Binxiang Medical Products Co., Ltd.2014-01-07
SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER (K132439)Sakura Seiki Co., Ltd.2014-01-06
NASAL EASE ALLERGY BLOCKER (K132520)Hi-Tech Pharmacal, Inc.2013-12-31
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU (K132007)Stericycle, Inc.2013-12-27
KINGTECH FOREHEAD THERMOMETER (K133113)Kingtech Enterprise, Ltd.2013-12-26
KINGTECH DIGITAL THERMOMETER (K133111)Kingtech Enterprise, Ltd.2013-12-26
SWABCAP AND SWABFLUSH (K130975)Excelsior Medical Corp.2013-12-24
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (K133634)Cook, Inc.2013-12-23
ONETOUCH REVEAL (K132618)Lifescan, Inc.2013-12-16
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE (K132484)Wrp Asia Pacific Sdn. Bhd.2013-12-13
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