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

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    TONOSHIELD TONOMETER SHIELD

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TARGETING ARM T2 PROX. HUM.

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 27, 2012

    PWRD ECH FLEX 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 22, 2013

    PINNACLE 100 ACET CUP 48MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·December 8, 2010

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 9, 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