BEUDAMED
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    ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PANOVIEW

    FDA UDI
    Richard Wolf GmbH·04055207021156·TELESCOPE 30° Ø 1.9MM SL 61MM rigid, TL 121mm,...

    Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

    FDA 510(k)
    FDA Class 2 ·Neurology

    AZE VIRTUALPLACE

    FDA 510(k)
    FDA Class 2 ·Radiology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 7, 2010

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 5, 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