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

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    ANIMAL AND HUMAN SERA

    FDA 510(k)
    FDA Class 1 ·Hematology

    Catalyst CSR Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SAPPHIRE PLASMA ARC DENTAL CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    HAKIM PROGRAMMABLE VALVE

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·October 6, 2010

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·February 18, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 17, 2012

    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