BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    PROGESTERONE ELISA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MicroPort Orthopedics Total Hip Systems MR Labeling

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REVISED LABELING FOR SYVA OPIATE ASSAYS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CARDINAL LEFT PRESOURCE CUSTOM KIT SCV561H19S

    FDA Adverse Event
    Injury ·Product code FMF·February 13, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAL

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·January 20, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·Product code OYC·August 1, 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