BEUDAMED
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    PULSE CRP TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRILL BIT Ø2.5 L180/155 2FLUTE

    FDA Adverse Event
    Malfunction ·SYNTHES·Product code HSZ·January 22, 2013

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 8, 2010

    R3

    FDA Adverse Event
    Injury ·SMITH&NEPHEW, INC·Product code LZO·July 9, 2014

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 27, 2024

    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