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

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    Aevumed PHANTOM Suture Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

    SYNCHROMED II

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·November 21, 2008

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

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

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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