BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    Biolox® Delta Revision heads

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PrecisionTAVI (v1.1)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 9, 2023

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·November 24, 2008

    INTRALASE PATIENT INFERFACE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·September 1, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·Product code OYC·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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