BEUDAMED
    7 results · 26ms · 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.

    PROTECT-AIDS UNDERGLOVE

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

    SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRECIMAT GLYCEROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2014

    FLEXTOME CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·October 22, 2010

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·December 19, 2012

    a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025