BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    STORZ/MAZZACCO LENS FORCEP

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

    FDA 510(k)
    FDA Class 2 ·Immunology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 7, 2010

    INTERSTIM

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code EZW·December 6, 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