BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    ELECTROSURGICAL DISP. DISPERSIVE PAD

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

    MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OLEA SPHERE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TISSUE-TEK PARAFORM PROCESSING/EMBEDDING MEDIUM FORMULA3 PARAFFIN

    FDA Adverse Event
    Malfunction ·SAKURA FINETEK U.S.A., INC.·Product code IEO·April 22, 2014

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 2, 2012

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 4, 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