BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

    FDA 510(k)
    FDA Class 2 ·Hematology

    MERON PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    METRON-CP/MD

    FDA 510(k)
    FDA Class 2 ·Radiology

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 6, 2023

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 11, 2013

    AMPLATZER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·July 11, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·September 17, 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