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

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    MODEL FT-100 INTRACRANIAL PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    HAMILTON-C2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Nihon Kohden SVM-7200 Series Vital Signs Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FPO·October 27, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 31, 2012

    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