BEUDAMED
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    CENTRIMED SYSTEM 1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DD cubeY® HL

    FDA UDI
    Dental Direkt GmbH·EDDIG8420071·The DD cubeY® HL zirconium dioxide milling blan...

    ZOLL E SERIES DEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PEDIWET=GUAZE IMPREGNATED WITH PETROL

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

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 31, 2014

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS·Product code GEX·November 14, 2012

    REPAIR CORE MICRO DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·August 26, 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