meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
29
Latest Decision
2014-07-09

Clearances · page 30 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K141245 ETEX MIXING AND DELIVERY SYSTEM Etex Corporation FMF Class II 2014-07-09
K141102 HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE Hospira, Inc. FRN Class II 2014-07-08
K140816 POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) Better Care Plastic Technology Co., Ltd. LZA Class I 2014-07-08
K141151 CT MIDLINE Medcomp (Medical Components, Inc.) LJS Class II 2014-07-08
K141117 EZ-IO INTRAOSSEOUS INFUSION SYSTEM Vidacare, LLC FMI Class II 2014-07-08
K132761 WIRELESS THERMOMETER Raiing Medical Company FLL Class II 2014-07-08
K141273 WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE Welldoc, Inc. MRZ Class II 2014-07-08
K132543 INFANT INCUBATOR Bistos Co., Ltd. FMZ Class II 2014-07-03
K133689 POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK Pt. Medisafe Technologies LZA Class I 2014-07-03
K132354 POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE Advanced Health Products, Lot 60 & 61 LZA Class I 2014-06-30
K140243 SHUNTONG Shuntong Glove Co., Ltd. LYZ Class I 2014-06-30
K140289 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM Summit Medical, Inc. KCT Class II 2014-06-27
K133193 RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) Riverstone Resources Sdn Bhd LZA Class I 2014-06-23
K140610 NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) Hartalega NGC Sdn. Bhd. LZA Class I 2014-06-20
K133147 BRACCO INJEENERING TRANSFER SET Bracco Injeneering S.A. PQH Class II 2014-06-20
K130733 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Benteng Plastic Co., Ltd. LYZ Class I 2014-06-18
K133635 EASYPOINT NEEDLE Retractable Technologies, Inc. FMI Class II 2014-06-17
K140708 VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR STERIS Corporation FRC Class II 2014-06-16
K140799 CELERITY SYSYEM Medcomp (Medical Components, Inc.) LJS Class II 2014-06-13
K140239 JIAWANG Jiawang Glove Co., Ltd. LYZ Class I 2014-06-12
K133280 TERUMO SURFLO I.V. CATHETER Terumo (Philippines) Corporation FOZ Class II 2014-06-12
K140730 VIAL2BAG DIRECT CONNECT Medimop Medical Projects, Ltd. LHI Class II 2014-06-12
K140322 WHITE VINYL EXAM GLOVES POWDER FREE Shandong Dawei Medical Products Co., Ltd. LYZ Class I 2014-06-12
K141306 TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE Teva Medical Ltd., Migada Plant FPA Class II 2014-06-12
K140242 FEIYUE Feiyue Glove Co., Ltd. LYZ Class I 2014-06-12
K140240 ZHAOFENG Zhaofeng Glove Co., Ltd. LYZ Class I 2014-06-12
K132557 EWNL SAFETY SYRINGE WITH NEEDLE Jiamei-Un Co., Ltd. FMI Class II 2014-06-03
K133478 POWDER FREE POLYETHYLENE EXAMINATION GLOVES Shijiazhuang Hongzan Plastic Technology Co.,Ltd LZA Class I 2014-06-02
K141138 SURFLASH SAFETY I.V. CATHETER Kofu Factory of Terumo Corp. FOZ Class II 2014-05-30
K133123 NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F Yty Industry (Manjung) Sdn Bhd LZA Class I 2014-05-30
K131954 MEDI PEN NEEDLE Shanghai Carelife International Trading Co. , Ltd. FMI Class II 2014-05-29
K133956 NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN Hartalega Sdn Bhd LZA Class I 2014-05-28
K133953 LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M Hartalega Sdn Bhd LYY Class I 2014-05-28
K132681 SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE Sol-Millennium Medical, Inc. MEG Class II 2014-05-22
K133351 NEXUS NIS-6P LUER ACTIVATED DEVICE Nexus Medical, LLC FPA Class II 2014-05-22
K140169 VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM Cook Incorporated LJT Class II 2014-05-21
K134043 NO TOUCH+FOREHEAD NTF 3000 THERMOMETER Kaz USA, Inc (A Subsidiaryof Kaz Inc) FLL Class II 2014-05-21
K133738 NOVOFINE PLUS 32G 4 MM Novo Nordisk, Inc. FMI Class II 2014-05-21
K132291 NAMSA CHEMICAL PROCESS North American Science Assoc., Inc. JOJ Class II 2014-05-20
K140133 INFUSET FLOW CONTROL EXTENSION SET Emed Technologies Corporation FPA Class II 2014-05-15
K140591 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR Becton, Dickinson & CO ONB Class II 2014-05-14
K140568 CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT Facet Technologies, LLC FMI Class II 2014-05-13
K132899 EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) Equashield Medical , Ltd. ONB Class II 2014-05-13
K140419 SUPERCATH5 Togo Medikit Co., Ltd. FOZ Class II 2014-05-12
K131531 TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE Anhui Tiankang Medical Products Co., Ltd. MEG Class II 2014-05-12
DEN130015 PIXEL 3 SYSTEM Gauss Surgical, Inc., PBZ Class II 2014-05-09
K133801 BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY Baxter Healthcare Corporation FRN Class II 2014-05-07
K140311 CARESITE LUER ACCESS DEVICE B.Braun Medical, Inc. FPA Class II 2014-05-07
K122656 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR Shandong Yifan Plastic Products Co., Ltd. LYZ Class I 2014-05-06
K133204 AIRVIEW MINI OWIE DICK TEST PACK Crosstex International JOJ Class II 2014-05-05
K132476 SHARPS CONTAINER Grp & Associates MMK Class II 2014-05-02
K132637 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR Zibo Intco Medical Products Co., Ltd. LYZ Class I 2014-05-01
K133870 FLUID LEVEL MONITOR Coleman Laboratories FLN Class II 2014-04-24
K140442 MEDSOURCE SELECTABLE IV SET Medsource International, LLC LHI Class II 2014-04-22
K140831 MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR Care Fusion FPA Class II 2014-04-15
K140194 NAMIC RCS SYRINGE Navilyst Medical, Inc. FMF Class II 2014-04-14
K122176 POWDERED VINYL EXAMINATION GLOVES Shu Tong Xinghua Co., Ltd. LYZ Class I 2014-04-11
K122377 POWDER FREE VINYL EXAMINATION GLOVES Shu Tong Xinghua Co., Ltd. LYZ Class I 2014-04-11
K133949 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS Top Calibre Sdn Bhd LZA Class I 2014-04-08
K140402 MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET Medsource International, LLC LHI Class II 2014-04-03
K140131 SUB-Q SUBCUTANEOUS TISSUE INFUSION SET Emed Technologies Corporation FPA Class II 2014-04-03
K133116 VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC Conmed Corporation KCT Class II 2014-03-28
K130263 STERRAD 50/100S/200 TEST PACK Advanced Sterilization Products FRC Class II 2014-03-28
K133493 SINGLE USE STERILE SYRINGE WITH NEEDLE Jiangxi Kelun Medical Devices Manufacturing Co.,Lt FMF Class II 2014-03-27
K133593 T:SLIM INSULIN DELIVERY SYSTEM Tandem Diabetes Care, Inc. LZG Class II 2014-03-24
K132011 APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET Aea Srl FMF Class II 2014-03-21
K133073 CAIR DRIVE, NEUTRACLEAR Cair Lgl FPA Class II 2014-03-20
K133894 SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V. FPA Class II 2014-03-18
K131210 ELECTRONIC THERMOMETER Shenzhen Pump Medical System Co., Ltd. FLL Class II 2014-03-18
K140345 THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) C.R. Bard, Inc. LJS Class II 2014-03-14
K133015 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM Summit Medical, Inc. KCT Class II 2014-03-13
K133097 E-Z LINK Duoject Medical Systems, Inc. LHI Class II 2014-03-13
K131708 BWCSH-1 SHARPS CONTAINER Bradford Wright Companies, Inc. MMK Class II 2014-03-10
K130751 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Cabin Plastic Co., Ltd. LYZ Class I 2014-03-05
K140266 NMI PICC IV Navilyst Medical, Inc. LJS Class II 2014-03-05
DEN080009 AIRPURGE Anesthesia Safety Products, LLC OKL Class II 2014-03-04
K132553 U&U STERILE PISTON SYRINGE WITHOUT NEEDLE U&U Medical Technology Co, Ltd. FMF Class II 2014-02-27
K123162 U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL U&U Medical Technology Co, Ltd. FRG Class II 2014-02-26
K133059 INSULIN PEN NEEDLE Wenzhou Beipu Science & Technology Co., Ltd. FMI Class II 2014-02-25
K133058 INSULIN PEN NEEDLE Wenzhou Wuzhou Import & Export Co., Ltd. FMI Class II 2014-02-25
K132457 FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER Biocare Asia Corporation , Ltd. FLL Class II 2014-02-21
K132321 JMS SYRINGE JMS North America Corporation FMF Class II 2014-02-20
K131196 INFANT PHOTOTHERAPY BILITRON SKY 5006 Fanem Lda LBI Class II 2014-02-20
K130800 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Kaixuan Plastic Co., Ltd. LYZ Class I 2014-02-18
K130809 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Jewel Plastic Co., Ltd. LYZ Class I 2014-02-18
K130891 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Friend Plastic Co., Ltd. LYZ Class I 2014-02-18
K140136 NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE Nipro Medical Corporation FOZ Class II 2014-02-14
K133335 POWERPORT IMPLANTABLE PORT C.R. Bard, Inc. LJT Class II 2014-02-14
K131154 ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; Zevex, Inc. LZH Class II 2014-02-12
K131033 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Decent Plastic Co., Ltd. LYZ Class I 2014-02-12
K123537 POWDER FREE LATEX EXAMINATION GLOVES Qube Medical Product Sdn Bhd LYY Class I 2014-02-12
K132583 EZ-IO INTRAOSSEOUS INFUSION SYSTEM Vidacare Corporation FMI Class II 2014-02-11
K133267 DANA REUSABLE TEST PACK Dana Products, Inc. FRC Class II 2014-02-11
K130807 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Hope Plastic Co., Ltd. LYZ Class I 2014-02-07
K133263 PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) Proteus Digital Health, Inc. OZW Class II 2014-02-07
K130890 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Air Plastic Co., Ltd. LYZ Class I 2014-02-06
K131341 POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Winful Plastic Co., Ltd. LYZ Class I 2014-02-06
K133867 SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V. FPA Class II 2014-02-05
K132140 DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER Duteck Industrial Co., Ltd. FLL Class II 2014-02-04
K130582 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Heze City Green Food Co., Ltd. LYZ Class I 2014-02-04

15,723 clearances in the General Hospital panel. Data: openFDA.