BEUDAMED
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    BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228708071·GC Initial™ MC Dentin DB2, 250g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556701024·GC Initial™ MC Dentin DB2, 250g

    ADENOVIRUS-GROUP FA LABELLED (8-651 RF)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 12, 2014

    VIPER MIS CANNULATED SCREW 6X40MM, TI

    FDA Adverse Event
    Injury ·DEPUY SPINE INC.·Product code NKB·October 11, 2010

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·December 12, 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