BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    CLINPRO PROPHY POWDER

    FDA 510(k)
    FDA Class 2 ·Dental

    T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CELLTRACKS AUTOPREP SYSTEM MODEL:9541

    FDA 510(k)
    FDA Class 1 ·Hematology

    ZOLL IVTM QUATTRO CATHETER

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code NCX·July 14, 2020

    WIRE, GUIDE, CATHETER

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC·Product code DQX·July 14, 2020

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 31, 2013

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 15, 2011

    BROACH HANDLE POST LEVERED

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·August 27, 2008

    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