BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    AST S.C.E. (GOT)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SAF FIXATIVE

    FDA 510(k)
    FDA Class 1 ·Pathology

    C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·October 9, 2010

    IDENTITY ADX XL DR

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·December 10, 2012

    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