BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia

    FDA 510(k)
    FDA Class 2 ·Dental

    GENESIS REUSABLE RIGID CONTAINER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COPIOS PERICARDIUM MEMBRANE

    FDA Adverse Event
    Injury ·Product code NPL·June 10, 2020

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 22, 2014

    CLAMP RADIOLUC

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KTT·June 27, 2013

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·June 30, 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