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

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    REM-AIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ORTHO-PLEX-REHABILITATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    THERMO-FLOW SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 22, 2013

    SAGITTAL SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·December 9, 2010

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 10, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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