BEUDAMED
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    ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT

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

    Vesco Medical Extension Feeding Set

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

    O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 7, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 7, 2011

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·August 8, 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