BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    NICOLET VIKING II SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRUEBALANCE BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Transferrin

    FDA 510(k)
    FDA Class 2 ·Immunology

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014

    TRUE BALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 16, 2014

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·January 22, 2015

    PENTA

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 4, 2014

    PIONEER PLUS CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC INC.·Product code DQY·December 31, 2012

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·October 28, 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