BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Somnera System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MASTERSCREEN CPX AND OXYCON CPX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·November 10, 2014

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·September 9, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 22, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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