BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ELECTROSURGICAL UNIT 774

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Biodesign Enterocutaneous Fistula Plug

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GRT LITE, MODEL 8-A

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    25KHZ STRAIGHT TIP

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code LFL·June 5, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·October 1, 2010

    ALIGN S URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LTD·Product code FTL·November 20, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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