BEUDAMED
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    Tablo Hemodialysis System (PN-0008000, PN-0006000U)

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

    FLEXISCOPE, MODELS 50MH AND 50 MHC

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Sleep Profiler

    FDA 510(k)
    FDA Class 2 ·Neurology

    STORZ KOCH STOP AND CHOP MANIPULATOR

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HNR·November 12, 2014

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code FNL·August 3, 2011

    CORAIL2 STD SIZE 11

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 29, 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