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

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    BASIS FLOW II

    FDA 510(k)
    FDA Class 2 ·Dental

    WATCH-PAT200U (WP200U)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    REZOOM

    FDA Adverse Event
    Injury ·ADVANCED MEDICAL OPTICS·Product code MFK·November 13, 2008

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 4, 2011

    TPS HANDPIECE CORD

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·July 18, 2013

    UNKNOWN

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 20, 2025

    Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

    FDA Enforcement
    Class II ·Ongoing·Remel Europe Ltd.·April 29, 2026

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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