BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    TRIGLYCERIDES REAGENT SET TAG-GK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·February 28, 2014

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KXA·November 7, 2012

    CENTURY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·August 30, 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