BEUDAMED
    7 results · 19ms · 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.
    Filters Regulation: Us FDA ×

    JANSEN-ANDERSON INSEMINATION SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ROMFLEX REHAB EQUIP EXTREMITIES UNIT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CATH-FINDER(TM) CATHETER TRACKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIM·January 14, 2013

    SURGILAV

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS·Product code FQH·November 17, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 3, 2014

    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