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

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    DELUXE KNEE IMMOBILIZER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788231590·DLIF Rasp 14x18mm

    SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PLUM XLM W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 19, 2014

    CARPENTIER-EDWARDS® BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 7, 2012

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 7, 2015

    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