BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    HDL/CHOLESTEROL TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    s-Clean OneQ-SL Narrow Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    MUCOGRAFT

    FDA 510(k)
    FDA Class 2 ·Dental

    VIRTUOSO

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

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 1, 2010

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·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