BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    Disposable Sterilized Latex Surgical Gloves

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NAUTILUS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 29, 2014

    ENCORE BALLOON CATHETER INFLATION DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MAV·August 15, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENSTONE METAL·Product code ITJ·July 8, 2013

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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