BEUDAMED
    7 results · 24ms · Sources: EU EUDAMED, US FDA

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    MODEL 228-02 THINLITH II PACEMAKER, BIPO

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    RELiZORB

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FETAL MONITORING SYS. MODEL FM3R

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 5, 2014

    VERSA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·October 15, 2012

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·May 22, 2015

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025