BEUDAMED
    8 results · 33ms · 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.

    EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REYNOLDS DOUBLE HEMOCLIP APPLIERS

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

    Digital Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·June 24, 2014

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·October 29, 2010

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·HAEMONETICS CORP.·Product code CAC·December 20, 2012

    PAEDIATRIC CANNULA, VENOUS

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWF·June 7, 2023

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012