BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    BLU TOTALE (Model: ENEOB852)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRODENSE BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·August 24, 2011

    CAROTID WALLSTENT MONORAIL

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - GALWAY·Product code NIM·November 6, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 18, 2013

    ACCOLADE DR SL MRI (Model L311)

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