BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Artemis Proximal Femoral Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REPIPHYSIS LIMB SALVAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FORCETRIAD ENERGY PLATFORM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 17, 2011

    ANALYTICAL D MODULE

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

    NAVILYST MEDICAL

    FDA Adverse Event
    Malfunction ·NAVILYST MEDICAL·Product code DQX·July 2, 2013

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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