BEUDAMED
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    FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228746211·GC Initial™ Ti Cervical Transluc. CT-21, 50g

    BEHIND THE EAR HEARING AID BERNAFON T-88P

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ISOSTATION KNEE MACHINE (K-100)

    FDA 510(k)

    ZIMMER SKIN GRAFT MESHER COMPLETE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·April 24, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 19, 2010

    SCREW LOCKING

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 15, 2012

    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