BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    LENS-EZE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RS80A Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V

    FDA 510(k)
    FDA Unclassified ·Unknown

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code NIQ·October 8, 2010

    12/14 ARTICUL 40MM M SPEC+1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 7, 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