BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    INJECTION ASPIRATING NEEDLES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CODMAN® HOLTER®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780518112·CODMAN® HOLTER® In-Line Shunt Filter, Hoffman D...

    CODMAN HOLTER

    FDA UDI
    Cerenovus, Inc.·10886704040767·CODMAN HOLTER In-Line Shunt Filter, Hoffman Design

    GLUCOSE CONTROL SOLUTION FOR BD LATITUDE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FINGERTIP PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 20, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 6, 2012

    OT PROFILE METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 31, 2010

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012