BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    DANEK RING FIXATOR (DRF)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Patterson

    FDA UDI
    PATTERSON DENTAL SUPPLY, INC.·D6620708908141·POINT, PAPER, ENDODONTIC

    MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

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

    AccuFill Bone Substitute Material

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC. CRMD·Product code DXY·January 13, 2014

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·October 28, 2010

    BIOSTEON WEDGE INTERFERENCE SCREW

    FDA Adverse Event
    Malfunction ·BIOCOMPOSITES LTD.·Product code HWC·November 15, 2012

    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