BEUDAMED
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    Revogene

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FX SPS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOMNUM (V.1.1.2.)

    FDA 510(k)
    FDA Class 2 ·Neurology

    BLAZER

    FDA Adverse Event
    Malfunction ·PINGHU ASPEL TECH CORP·Product code ITJ·September 6, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    CORAIL AMT COLLAR SIZE 13

    FDA Adverse Event
    Injury ·Product code KWA·July 23, 2013

    ACCOLADE DR SL MRI (Model L311)

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