meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
37
Latest Decision
2012-05-03

Clearances · page 35 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K121182 VIALOK NON-VENTED Yukon Medical, LLC LHI Class II 2012-05-03
K113355 POSEY BED J. T. Posey Co. OYS Class I 2012-05-02
K120261 PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER Perouse Medical FPA Class II 2012-05-02
K120184 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED Encompass Medical Supplies Inc Limited LZA Class I 2012-05-02
K120168 LULLABY LED PHOTTHERAPY SYSTEM Wipro GE Healthcare Private, Ltd. LBI Class II 2012-05-02
K112924 RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME Riverstone Resources Sdn Bhd LZA Class I 2012-05-02
K120981 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC Medical Components, Inc. LJS Class II 2012-05-02
K120980 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC Medical Components, Inc. LJS Class II 2012-05-02
K120746 DISPOSABLE POWDER FREE VINYL EXAM GLOVES Canopus Medical Supply Co., Ltd. LYZ Class I 2012-04-27
K112535 GENESIS REUSABLE RIGID CONTAINER SYSTEM Carefusion 2200, Inc. KCT Class II 2012-04-27
K113837 POWDER FREE VINYL PATIENT EXAMINATION GLOVES Hebei Changsheng Plastic Products Co., Ltd. LYZ Class I 2012-04-27
K121106 TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET Surgical Appliance Industries, Inc. DWL Class II 2012-04-27
K120935 SECURACATH Interrad Medical, Inc. OKC Class II 2012-04-27
K113221 NAMSA BIOLOGICAL INDICATOR SPORE STRIPS North American Science Assoc., Inc. FRC Class II 2012-04-27
K111085 SHARPS TANK REUSABLE SHARPS CONTAINER Rehrig Pacific Company MMK Class II 2012-04-25
K120872 ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS Unomedical A/S Infusion Devices FPA Class II 2012-04-20
K111464 PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES Dipped Products (Thailand), Ltd. LZA Class I 2012-04-19
K112536 SONICISION STERILIZATION TRAY Covidien KCT Class II 2012-04-19
K113398 NEXUS TKO-6, LUER-ACTIVATED DEVICE Nexus Medical, LLC FPA Class II 2012-04-18
K112928 RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME Riverstone Resources Sdn Bhd LZA Class I 2012-04-17
K120117 CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM Codman & Shurtleff, Inc. KCT Class II 2012-04-16
K112290 SUPERCATH Z3V Togo Medikit Co., Ltd. FOZ Class II 2012-04-16
K120830 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) Carticept Medical, Inc. FRN Class II 2012-04-16
K113186 STERILE INSULIN PEN NEEDLE Shina Corp. FMI Class II 2012-04-12
K111547 BILI-THERAPY PAD TYPE Atom Medical Corporation LBI Class II 2012-04-12
K120209 PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE American I.V. Products, Inc. MRZ Class II 2012-04-12
K112073 INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK... Rx Devices, LLC FPA Class II 2012-04-11
K111924 FINESSE PERSONAL INSULIN DELIVERY PATCH Calibra Medical, Inc. OPP Class II 2012-04-10
K112110 STERILE LUBRICATING JELLY Jianerkang Medical Dressing Company KMJ Class I 2012-04-10
K120473 PIXEL APP Gauss Surgical, Inc., LWH Class I 2012-04-09
K111453 STEAM DOT BLU PROCESS INDICATOR Propper Mfg. Co., Inc. JOJ Class II 2012-04-05
K120190 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR Rich Mountain Medical Products, Inc. LYZ Class I 2012-04-02
K120799 ARISURE NEUTRAL VALVE Yukon Medical, LLC FPA Class II 2012-03-30
DEN110002 SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT STERIS Corporation OVY Class II 2012-03-30
K120206 MEDTRONIC MINIMED PARADIGM INSULIN PUMPS Medtronic Minimed LZG Class II 2012-03-29
K112702 IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS Imperial Surgical , Ltd. LGZ Class II 2012-03-29
K111703 INFRARED EAR THEROMETER Fudakang Industrial Co., Ltd. FLL Class II 2012-03-29
K112774 BD RECYKLEEN SHARPS COLLECTORS Becton, Dickinson and Company MMK Class II 2012-03-28
K110535 ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION Carefusion 303, Inc. FRN Class II 2012-03-26
K112012 NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES Ug Healthcare (Usa), Inc. LZA Class I 2012-03-21
K112005 NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Ug Healthcare (Usa), Inc. LYY Class I 2012-03-21
K102900 HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM Hei, Inc. LGZ Class II 2012-03-21
K113357 POSEY BED J. T. Posey Co. OYS Class I 2012-03-21
K110536 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Zibo Tengyue Plastic Products Co., Ltd. LYZ Class I 2012-03-19
K113808 THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) C.R. Bard, Inc. LJS Class II 2012-03-19
K113749 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR Full Synergy Medical Products, Inc. LYZ Class I 2012-03-15
K113700 VIAVALVE SAFETY IV CATHETER Smiths Medical Asd, Inc. FOZ Class II 2012-03-14
K102189 POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM Latexx Manufacturing Sdn.Bhd. LZC Class I 2012-03-14
K112902 ENFLOW IV FLUID WARMER Vital Signs, Inc. LGZ Class II 2012-03-14
K113429 SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER Nipro Medical Corporation FOZ Class II 2012-03-12
K113423 KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE Kimberly-Clark Corp. LZA Class I 2012-03-09
K113790 DISPOSABLE VINYL EXAM GLOVE, POWDERED Full Synergy Medical Products, Inc. LYZ Class I 2012-03-06
K120358 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) Hongxin Plastic Products Co., Ltd. LYZ Class I 2012-03-06
K113422 TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE Terumo (Philippines) Corporation FMI Class II 2012-03-05
K113750 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR Full Synergy Medical Products, Inc. LYZ Class I 2012-03-05
K110901 SYMBIQ INFUSION AND ADMINSTRATION SET Hospira, Inc. FRN Class II 2012-03-05
K113095 E-CARE INFRARED EAR THERMOMETER E-Care Technology Corporation FLL Class II 2012-03-02
K113797 DISPOSABLE VINYL EXAM GLOVE, POWDER FREE Full Synergy Medical Products, Inc. LYZ Class I 2012-03-02
K120304 FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER Footprint Medical, Inc. FOS Class II 2012-03-01
K112769 CURAD COMPRESSION HOSIERY Medline Industries, Inc. DWL Class II 2012-03-01
K111841 SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. FMF Class II 2012-03-01
K113587 AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) Shantou Wealy Medical Instrument Co.,Ltd MEG Class II 2012-02-24
K120314 WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM Welldoc, Inc. MRZ Class II 2012-02-24
K112777 SOL-M EXCHANGEABLE NEEDLES Sol-Milennium Medical, Inc. FMI Class II 2012-02-24
K113520 SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation MED Class II 2012-02-21
K113505 VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER Greiner Bio-One North America, Inc. FMI Class II 2012-02-17
K111463 VALEO VT-601 SERIES IR THERMOMETER Valeo Corp. FLL Class II 2012-02-17
K113206 NANOBLUTM 500 Draeger Medical Systems, Inc. LBI Class II 2012-02-17
K120337 I-PORT ADVANCE INJECTION PORT Unomedical A/S FOZ Class II 2012-02-16
K110748 OLYMPUS INSTRUMENT TRAY Olympus Winter & Ibe GmbH KCT Class II 2012-02-15
K113722 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR Full Synergy Medical Products, Inc. LYZ Class I 2012-02-14
K113710 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR Full Synergy Medical Products, Inc. LYZ Class I 2012-02-14
K111467 FLEXI-Q DV AND DVR AUTO-INJECTORS Elcam Medical Acal KZH Class II 2012-02-09
K112542 YOMURA SAFETY I.V. CATHETER Yomura Technologies, Inc. FOZ Class II 2012-02-08
K112591 SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS Safe Secure Packaging Co., Ltd. FRG Class II 2012-02-07
K113100 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS Maxter Glove Manufacturing Sdn Bhd LZA Class I 2012-02-06
K110550 BRIGHT EMBRACE MODEL SBL60 Physician Engineered Products, Inc. LBI Class II 2012-02-03
K112976 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM Hartalega Snd. Bhd. LZA Class I 2012-02-02
K111515 SPSMEDICAL SPORVIEW STEAM BI Spsmedical Supply Corp. FRC Class II 2012-02-01
K112018 SMART READ EZTEST STEAM Mesa Laboratories, Inc. FRC Class II 2012-01-30
K113555 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE Am USA NGT Class II 2012-01-30
K113015 ALDAHOL V HIGH LEVEL DISINFECTANT Microchem Laboratories, Inc. MED Class II 2012-01-30
K113842 CATHETER CONNECTIONS' DUALCAP SOLO Catheter Connections, Inc. QBP Class II 2012-01-27
K113141 MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1 Microlife Intellectual Property GmbH FLL Class II 2012-01-27
K110312 CLICKFINE AUTOPROTECT PEN NEEDLE Ypsomed AG FMI Class II 2012-01-26
K111134 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Siem Aempemed Corp., Ltd. LZA Class I 2012-01-26
K112904 STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS Case Medical, Inc. FRG Class II 2012-01-24
K112936 SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM Rexam Consummer Plastics Inc.D/B/A Rexam Pharma MEG Class II 2012-01-20
K113302 NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS North American Science Assoc., Inc. FRC Class II 2012-01-20
K112918 DURABLUE STERILIZATION (AMSCO V-PRO) WRAP Cardinal Health200, LLC FRG Class II 2012-01-20
K112300 KIMGUARD SMART-FOLD* STERILIZATION WRAP Kimberly-Clark Corp. FRG Class II 2012-01-19
K112612 POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM Top Calibre Sdn Bhd LYY Class I 2012-01-18
K110305 CRY-ACTRACKERCAM Brymill Cryogenic Cystems FQZ Class I 2012-01-13
K112189 THERMO PAL INFRARED EAR THERMOMETER Digio2 International Co., Ltd. FLL Class II 2012-01-13
K111381 MEDI-SIS SYRINGE INFUSION SYSTEM Acacia, Inc. LZH Class II 2012-01-13
K113683 LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL Hospira, Inc. FPA Class II 2012-01-12
K111992 CUROS PORT PROTECTOR Ivera Medical, Inc. QBP Class II 2012-01-12
K112811 SANICLAVE 200 Alternative Pioneering Research and Development FLE Class II 2012-01-11
K112256 STERIS STEAM PI STERIS Corporation JOJ Class II 2012-01-11
K112332 FINE JECT INSULIN PEN NEEDLE Twobiens Co., Ltd. FMI Class II 2012-01-10

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