BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    PERISCOPE VOICE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TRIA LASER HAIR REMOVAL SYSTEM

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

    CAT ACTIVE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DXTEND HIGHMO PE CUP D38 +3MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS REG. # 3003895575·Product code KWS·May 20, 2014

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 6, 2012

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·September 20, 2007

    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