BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Lung Analysis Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 9, 2025

    4 FR S/L GROSHONG NXT REPAIR KIT

    FDA Adverse Event
    Injury ·C. R. BARD INC. (BASD)·Product code LJS·December 4, 2008

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 12, 2011

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVN·July 29, 2013

    ACCOLADE DR SL MRI (Model L311)

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