BEUDAMED
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    REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209113507·

    Adaptivo

    FDA 510(k)
    FDA Class 2 ·Radiology

    LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)

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

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 6, 2014

    ITREL 3

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 30, 2012

    MICROPLEX HYPERSOFT HELICAL HYPERSOFT

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code HCG·June 16, 2015

    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