BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MALIBU SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RS80A Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARPENTIER-EDWARDS PERMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·December 1, 2008

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FRN·August 10, 2011

    ADVANTAGE FIT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 29, 2013

    ACCOLADE DR SL MRI (Model L311)

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