BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    REMOTE CONTROL SYSTEM FOR MICROSCOPE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MTS Gepotidacin 0.016-256 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACCLAIM TOTAL ELBOW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 11, 2014

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 26, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 13, 2010

    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 U228, VISIONIST CRT-P EL MRI

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