meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
25
Latest Decision
2010-11-03

Clearances · page 39 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102093 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Great Vision Plastic Products Co., LT LYZ Class I 2010-11-03
K102994 K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR Kawasumi Laboratories, Inc. FMI Class II 2010-11-03
K102074 POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) Gx Corporation Sdn Bhd LZA Class I 2010-11-02
K101917 COMFORT RUBBER GLOVES IND.SDN.BHD. Comfort Rubber Gloves Industries Sdn. Bhd. LYY Class I 2010-10-29
K102655 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE) Ever Light Plastic Products Co., Ltd. LYZ Class I 2010-10-29
K100660 INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 Innochips Technology Co., Ltd. FLL Class II 2010-10-22
K102611 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Hyland Plastic Co., Ltd. LYZ Class I 2010-10-21
K102890 K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) Kawasumi Laboratories America, Inc. FPA Class II 2010-10-21
K102559 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) Tangshan Hengda Plastic Products Co., Ltd. LYZ Class I 2010-10-21
K102569 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) Tangshan Kangyuan Glove Co., Ltd. LYZ Class I 2010-10-21
K102570 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) Tangshan Kangjie Glove Co., Ltd. LYZ Class I 2010-10-21
K101309 EXELINT ALUMINUM HUB BLUNT NEEDLES Exelint International, Co. LHI Class II 2010-10-20
K101351 NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT Ascend Eagle, Inc. LZA Class I 2010-10-15
K102774 VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER Greiner Bio-One North America, Inc. FMI Class II 2010-10-15
K102161 BLUE SAIL INNOVATION Shandong Blue Sail Innovation Co., Ltd. LYZ Class I 2010-10-08
K101594 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE Better Care Plastic Technology Cp., Ltd. LZA Class I 2010-10-08
K101760 ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES Profit Point Manufacturing Sdn Bhd LZA Class I 2010-10-06
K102089 GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES Grand Work Plastic Products Co., Ltd. LYZ Class I 2010-10-06
K102099 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Hong DI Plastic Products Co., Ltd. LYZ Class I 2010-10-06
K102094 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Grand Work Plastic Products Co., Ltd. LYZ Class I 2010-10-05
K102362 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Jiangsu Huayuan Gloves Co., Ltd. LYZ Class I 2010-10-04
K102160 STRETCH VINYL EXAMINATION GLOVE POWDER FREE Shandong Blue Sail Innovation Co., Ltd. LYZ Class I 2010-10-04
K102431 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Fuqiang Glove Co., Ltd. LYZ Class I 2010-10-04
K102096 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE Syntex Healthcare Products Co., Ltd. LZA Class I 2010-10-04
K101828 POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS Gx Corporation Sdn Bhd LYY Class I 2010-10-04
K101528 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM 3M Company JOJ Class II 2010-10-01
K101958 AMSINO I.V. ADMINISTRATION AND EXTENSION SETS Amsino International, Inc. FPA Class II 2010-09-29
K102098 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Hong DI Plastic Products Co., Ltd. LYZ Class I 2010-09-27
K100421 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Tangshan Yonkshun Glove, Co., Ltd. LYZ Class I 2010-09-27
K102462 SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation MED Class II 2010-09-21
K101906 SHAPE TO FIT COMPRESSION WEAR Tsung Hau Technology Co., Ltd. DWL Class II 2010-09-17
K092551 SMITH & NEPHEW INSTRUMENT TRAYS Smith & Nephew Inc., Endoscopy Div. KCT Class II 2010-09-14
K102230 NUGARD NITILE GREY COLOR Terang Nusa Sdn Bhd LZA Class I 2010-09-10
K101249 STERIGAGE MODEL 1243RA, 1243RB, 1243RE 3M Company JOJ Class II 2010-09-08
K101646 NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR Sgmp Co., Ltd. LZA Class I 2010-09-08
K102032 KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS Kimberly-Clark Corp. LZA Class I 2010-09-08
K101630 POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE Pt. Smartglove Indonesia LZA Class I 2010-09-07
K101799 POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE Wear Safe (Malaysia) Sdn. Bhd. LYY Class I 2010-09-03
K102178 EASY TOUCH Mhc Medical Products FMF Class II 2010-09-02
K101567 SHARPS CONTAINER Cixi Leinuo Plastic Co., Ltd. MMK Class II 2010-09-02
K101326 NMI IC Navilyst Medical, Inc. LJS Class II 2010-09-02
K100124 FASTX STERNAL INTRAOSSEOUS DEVICE Pyng Medical Corp. FMI Class II 2010-08-31
K100998 1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1 Unilife Medical Solutions Limited MEG Class II 2010-08-30
K100622 BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 Belimed Sauter AG FLE Class II 2010-08-27
K101196 ACCU-CHEK ULTRFLEX INFUSION SET Roche Diagnostics Corp. FPA Class II 2010-08-27
K100635 ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 Arrow Intl., Inc. LJS Class II 2010-08-27
K101645 NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF Latexx Manufacturing Sdn.Bhd. LYY Class I 2010-08-26
K101358 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Hebei Handform Plastic Products Co., Ltd. LYZ Class I 2010-08-24
K093510 LUMENVU CATHETER GUIDANCE SYSTEM Sonosite,Inc. OMF Class II 2010-08-23
K101359 INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) Inviro Medical Devices, Inc. FMF Class II 2010-08-20
K093043 ZIRCONIA SYRINGE NEEDLE Kuo Tai Hospital Managements & Consultant Co., Ltd. FMI Class II 2010-08-20
K101329 SYNERGY CT PICC Health Line International Corporation LJS Class II 2010-08-19
K100975 NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE Jiangsu Sunshine Plastic Products, Co., Ltd. LZA Class I 2010-08-17
K100843 ABREU, MODEL 700 Brain Tunnelgenix Technologies Corp FLL Class II 2010-08-17
K100988 HUMAPEN LUXURA HD Eli Lilly and Company FMF Class II 2010-08-17
K101565 POWDER - FREE PATIENT EXAMINATION GLOVES Zibio Yingjie Medical Products Co., Ltd. LYZ Class I 2010-08-17
K100977 PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE Jiangsu Sunshine Plastic Products, Co., Ltd. LYZ Class I 2010-08-12
K100978 POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE Jiangsu Sunshine Plastic Products, Co., Ltd. LYZ Class I 2010-08-12
K100551 ORLOCATE SYSTEM MODEL ORL 100 Haldor Advanced Technologies, Ltd. LWH Class I 2010-08-12
K101677 HOSPIRA INFUSION BLOOD SETS Hospira, Inc. FPA Class II 2010-08-11
K100887 VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY Tag Medical Products KCT Class II 2010-08-09
K100963 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Hebei Shenzichen Plastic & Rubber Products Co., LT LYZ Class I 2010-08-06
K101595 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE Better Care Plastic Technology Cp., Ltd. LZA Class I 2010-08-06
K101747 BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE Kaz USA, Inc (A Subsidiaryof Kaz Inc) FLL Class II 2010-08-04
K092892 1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 I-Ming Sanitary Materials Co., Ltd. DWL Class II 2010-08-03
K101387 DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN Fudakang Industries Co., Ltd. FLL Class II 2010-08-03
K101180 GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, Smiths Medical MD, Inc. FPA Class II 2010-08-03
K100946 INTRAVSCULAR ADMINISTRATION SET Terumo Europe N.V. FPA Class II 2010-08-02
K101653 MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES Miltex, Inc. KCT Class II 2010-08-02
K101409 SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM STERIS Corporation MED Class II 2010-08-02
K093489 IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY Rymed Technologies, Inc. FPA Class II 2010-07-29
K101322 JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 Joinsoon Electronics Mfg Co, Ltd. FLL Class II 2010-07-28
K101663 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Hebei Excellent Plastic Co., Ltd. LYZ Class I 2010-07-27
K093493 AESCULAP STERILCONTAINER S Aesculap, Inc. FRG Class II 2010-07-27
K101026 POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO Vidacare Corporation FMI Class II 2010-07-27
K101664 POWDERED VINYL PATIENT EXAMINATION GLOVES Hebei Excellent Plastic Co., Ltd. LYZ Class I 2010-07-27
K100640 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 B.Braun Medical, Inc. LHI Class II 2010-07-22
K100488 IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 Shenzhen Dongdixin Technology Co., Ltd. FLL Class II 2010-07-22
K101804 GIRAFFE AND PANDA WARMERS Ohmeda Medical, A Division of Datex-Ohmeda, Inc. FMT Class II 2010-07-21
K101788 GIRAFFE OMNIBED Ohmeda Medical FMZ Class II 2010-07-21
K101043 ECT DIGITAL THERMOMETER Changshan Estar Electronics Co., Ltd. FLL Class II 2010-07-21
K101232 JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001 Joinsoon Electronics Mfg Co, Ltd. FLL Class II 2010-07-21
K101778 GIRAFFE INCUBATOR Ohmeda Medical FMZ Class II 2010-07-21
K101596 KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- Kimberly-Clark LZC Class I 2010-07-21
K100603 RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) Riverstone Resources Sdn Bhd LZA Class I 2010-07-16
K101841 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shijiazhuang Sail Plastic Co., Ltd. LYZ Class I 2010-07-16
K101840 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Shijiazhuang Sail Plastic Co., Ltd. LYZ Class I 2010-07-16
K100964 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Hebei Shenzichen Plastic & Rubber Products Co., LT LYZ Class I 2010-07-16
K100611 RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) Riverstone Resources Sdn Bhd LYY Class I 2010-07-16
K101343 POWDERED VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Star Plastic Co., Ltd. LYZ Class I 2010-07-16
K093775 EVGUIDE TIP LOCATION SYSTEM Romedex International Srl LJS Class II 2010-07-15
K100066 DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 Welldoc, Inc. MRZ Class II 2010-07-15
K101109 VIVATRAK Wireless Medcare, LLC KMI Class I 2010-07-15
K100907 NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL Siam Sempermed Corp., Ltd. LYY Class I 2010-07-09
K100434 CLAVE NEUTRON Icu Medical, Inc. FPA Class II 2010-07-09
K100432 POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS Medtronic Minimed FPA Class II 2010-07-09
K092306 SECURACATH UNIVERSAL Interrad Medical, Inc. LJS Class II 2010-07-09
K100057 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) Tangshan Kangyuan Glove Co., Ltd. LYZ Class I 2010-07-08
K100705 ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 Zyno Medical, LLC FRN Class II 2010-07-08
K101736 NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED Shenzhen Everbest Machinery Industry Co., Ltd. FLL Class II 2010-07-06

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