BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    SM-RNP AUTOANTIBODY TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CSS CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Certex Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code DQY·June 10, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 5, 2012

    STENOSCOPE

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)·Product code JAA·September 27, 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