BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Osstell Beacon

    FDA 510(k)
    FDA Class 1 ·Dental

    SCENARIA WHOLE-BODY X-RAY CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 5, 2019

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·June 21, 2013

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·July 28, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008

    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