BEUDAMED
    8 results · 31ms · Sources: EU EUDAMED, US FDA

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    GEL-BEAD EMBOLIZATION SPHERES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STEM COLLARED HA COATED STD STEM SIZE 9 LOT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 25, 2018

    LANX SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE

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

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 1, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·May 29, 2013

    L9000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code GCT·May 11, 2011

    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