BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    QUANTEM (TM)

    FDA 510(k)
    FDA Class 1 ·Radiology

    Sterile and Non-Sterile Ultrasound Gels

    FDA 510(k)
    FDA Class 2 ·Radiology

    MADSEN ACCUSCREEN TYPE 1077

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADVIA CENTAUR TOTAL HCG (THCG) AND PROGESTERONE

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHI·March 5, 2010

    DARWIN*CR/SB PS TB IN 10M/SZ 3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 29, 2013

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·December 13, 2010

    ECHELON LINEAR CUTTER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 14, 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