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

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    ABBOTT LABORATORIES STREP A EIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANTEGRADE FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSASTEP PLUS 12MM CANN/DILT W/RADEXPS1

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GCJ·October 8, 2012

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 19, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 27, 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