BEUDAMED
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    Esthetic Colorant

    FDA 510(k)
    FDA Class 2 ·Dental

    SAFESTEP 20G X 3/4 STRAIGHT

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code FPA·April 28, 2009

    ELECSYS ANTI-TG CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COMPLETE MULTIPURPOSE EASY RUB FORMULA

    FDA Adverse Event
    Malfunction ·ADVANCED MEDICAL OPTICS, INC.·Product code LPN·October 31, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    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