BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    HYTEC AUTOMIMMUNE KIT (DS-DNA)

    FDA 510(k)
    FDA Class 2 ·Immunology

    FIAX LYME M TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    KEYES SKIN PUNCH

    FDA 510(k)

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 16, 2017

    MEDTRONIC.SIGMA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NVZ·February 11, 2013

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    UNK NEXGEN LPS-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·July 16, 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