BEUDAMED
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    CERTAIN(R) ELITE LEVEL 1, 2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704268584·

    REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 19, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·January 4, 2013

    ACUITY

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·January 4, 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