BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    FA TISSUE FIXATIVE & WASH SET

    FDA 510(k)
    FDA Class 1 ·Pathology

    ABX PENTRA 400 : CRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    St. Louis Band

    FDA 510(k)
    FDA Class 2 ·Neurology

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 13, 2007

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·September 26, 2012

    LIFEVEST WCD 4000 SYS

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·December 31, 2013

    ACCOLADE DR EL MRI (Model L331)

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