BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    NANOSEP N10

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704263046·

    ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

    DESERET GUIDEWIRE INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·June 23, 2014

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·January 4, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·December 14, 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