BEUDAMED
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    MICRO-SURGICAL POWER INSTRUMENT SYS.

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

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268214871·CUSTOM SURGICAL KIT VEIN PACK

    LITECURE THERAPY COMPACT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SIMPLICITY EASY ACCESS P INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 20, 2014

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 6, 2012

    SHILEY LOW PRESSURE CUFFED

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCO HEATLHCARE·Product code JOH·August 25, 2010

    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