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

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    FRASER HARLAKE NITRONOX SCAVENGER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T2 FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 20, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 6, 2012

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 25, 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