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

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    OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    StageOne Select Cement Spacer Molds for Temporary Hip Replacement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    KAPPA 900 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DXY·June 10, 2014

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 4, 2010

    ST104 TRANSPORT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·November 2, 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