BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    Minimally Invasive Prostate Surgery Navigation System

    FDA 510(k)
    FDA Class 2 ·Radiology

    FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 31, 2024

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·August 24, 2011

    COBAS E411 RACK SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·November 5, 2008

    UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 11, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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