BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    Rusch Simplastic Foley Catheters

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

    AQUILION CXL

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATTAIN ABILITY PLUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·October 10, 2014

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 11, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 15, 2011

    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