BEUDAMED
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    TITERTEK DULUTER/DISPENSER 78-640-00

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COULTER COUNTER M2

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACTIVE LIFE ONE-PIECE CLOSED-END POUCH

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·June 3, 2014

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH. LTD./ HUNTINGTON·Product code HQL·November 16, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·June 15, 2015

    Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·July 2, 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