BEUDAMED
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    METHADONE EIA ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PRESTIGE® LP Cervical Disc System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994490339·GUIDE 6972526 CUTTER

    MICRUS COURIER ENZO MICROCATHETER 0.0190

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE GENERATOR, MODEL NO. LIT 222

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code INK·December 20, 2010

    ASSY, PROBE, BLADDERSCAN BVI 9400/9600

    FDA Adverse Event
    Malfunction ·VERATHON MEDICAL·Product code IYO·February 15, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 1, 2014

    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