BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Access anti-HAV

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Q2 Blood Administration Sets

    FDA 510(k)
    FDA Class 2 ·General Hospital

    iLet® ACE Pump

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD VACUTAINER® C&S TRANSFER STRAW KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JSM·May 7, 2019

    PROXIMATE*VASC LIN STAP RELOAD

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 11, 2014

    PFNA BLADE L95 TAN

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code KTT·September 7, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 23, 2013

    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