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

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    INCUS/STAPES PROSTHESIS

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

    EVEREST Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TURBOHAWK

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MCW·May 20, 2014

    SPINAL CORD STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONICS·Product code LGW·October 4, 2010

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 7, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012