BEUDAMED
    8 results · 30ms · Sources: EU EUDAMED, US FDA

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    MINI-DIAMOND KNIFE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CRUSADER HYPEREXTENSION BRACE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    GSI Audera Pro

    FDA 510(k)
    FDA Class 2 ·Neurology

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·October 4, 2023

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 24, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 2, 2013

    STELLARIS OPTIMIZED STABILITY VACUUM PACK

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQE·October 28, 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