BEUDAMED
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    Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EASYRA UREA NITROGEN AND CREATININE REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 6, 2008

    PLV-100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·June 24, 2013

    XPRT SLEEP SURFACE

    FDA Adverse Event
    Malfunction ·STRYKER CORP. DBA GAYMAR·Product code FNM·July 29, 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