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

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    Access TPO Antibody

    FDA 510(k)
    FDA Class 2 ·Immunology

    THE STRAUMANN ORTHO IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MR SYRINGE DUAL PACK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Death ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 20, 2008

    IRRIGATION TUBING AND CLIPS, HI-FLOW

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·July 17, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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