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

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    SURGITA/MIZHO MICRONEUROSURGERY HEAD FR

    FDA 510(k)
    FDA Class 2 ·Neurology

    NeuroRPM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1

    FDA 510(k)
    FDA Class 2 ·Radiology

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code IKX·May 20, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 6, 2012

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·August 26, 2010

    OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015