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

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    BAROguard Donor Lung Preservation System

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

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517632272·CoRoent Ant TLIF Ti, 15x14x30mm 15°

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·February 5, 2002

    Reprocessed Agilis NxT Steerable Introducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ultra-Fast Vitri; Ultra-Fast Warm

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

    CONTAK RENEWAL 3

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 19, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 25, 2013

    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