BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    SURGICAL NEEDLE GUIDE

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

    Transcranial Doppler Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ROC LUMBAR PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    1X8 TEST STIMULATION LEAD

    FDA Adverse Event
    Malfunction ·VILLABA·Product code GZB·October 22, 2010

    FORTIFY VR, DF-4 CONNECTOR

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

    PROTECTA XT VR

    FDA Adverse Event
    Death ·IPG MFG SWITZERLAND·Product code LWS·December 28, 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