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

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    BioTraceIO Precision (2.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    PREMERE DELIVERY SHEATH, MODEL PDS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ablamap Software

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZIMMER SKIN GRAFT MESHER

    FDA Adverse Event
    Malfunction ·ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS·Product code FZW·November 21, 2008

    ATLAS PLUS VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2011

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 23, 2013

    BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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