BEUDAMED
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    NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES

    FDA 510(k)
    FDA Class 1 ·Dental

    MIRADAPT* POLISHING INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Dental

    I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

    FDA 510(k)
    FDA Class 2 ·Hematology

    BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code MBI·April 27, 2012

    MEDISENSE OPTIUM

    FDA Adverse Event
    Injury ·Product code NBW·January 26, 2011

    INSIGNIA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 31, 2014

    DURACON CRUC NON BED B/P M2

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·May 13, 2008

    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