BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    AMBULARM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GIS ENDOSCOPIC OPTICAL LENS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 30, 2014

    ACU-LOC 1 PLATES

    FDA Adverse Event
    Malfunction ·ACUMED LLC·Product code HRS·April 19, 2012

    PATIENT ROOM WALL SAVER RECL

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FRK·September 10, 2010

    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