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

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    HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT

    FDA 510(k)
    FDA Class 1 ·Dental

    Automatic Arm Bluetooth Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COMBI SCAN100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VIVA XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code NIK·June 10, 2014

    PERIGEE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·November 27, 2012

    CONCERTO CRT-D DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·October 8, 2010

    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