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

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    VersaViewer

    FDA 510(k)
    FDA Class 2 ·Radiology

    Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Cuptimize

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·July 27, 2011

    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·November 11, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2013

    ACCOLADE DR SL MRI (Model L311)

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