BEUDAMED
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    BIRD (IPV) NONCONTINUOUS VENTILATORS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756639088·SHOULDER PACK

    ANGIOTEC FMX-2220 SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    WANG FRONT LOADING APPLICATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 25, 2014

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 3, 2013

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·November 4, 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