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

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    AS/3 NETWORK LINK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127023170·Double Offset Broach Handle Right

    ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSUREFIXNOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code MAF·January 7, 2011

    MINIPOLYAXIAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code HXX·July 23, 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