BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

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    B R A H M S PCT sensitive KRYPTOR

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NEWFIX EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLEX ARM RETRACTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    4.5MM TI BROAD LCP PLATE

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·July 18, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·June 14, 2013

    MAXI SKY 600

    FDA Adverse Event
    Malfunction ·BHM MEDICAL, INC.·Product code FNG·September 17, 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