BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    MERETE LOCKING BONE PLATE SYSTEM III

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERDICT-II PROPOXYPHENE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LENSX LASER SYSTEM

    FDA Adverse Event
    Injury ·ALCON - LENSX INC.·Product code OOE·May 8, 2014

    LEAD MODEL 304

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·November 6, 2012

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 31, 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