BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UCP HOME DRUG SCREENING TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VENTRE/SEP T3 TEST SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·November 5, 2010

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 7, 2012

    TENDRIL STS

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·June 24, 2014

    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