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

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    SURGICAL HEMOSTATS

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

    SOLO INSULIN PATCH PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PDS Barbed Suture, PDO MAXX Threads

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·October 22, 2010

    RIATA ST PASSIVE FIXATION

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

    OT PING METER

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