BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    Admira Fusion

    FDA 510(k)
    FDA Class 2 ·Dental

    HHM

    FDA UDI
    Oticon A/S·05707131281401·H150V2, BTE 13 WL 85 TC HHM

    UC-CARE NAVIGO SYTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NICHOLS ADVANTAGE ALDOSTERONE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD ULTRA-FINE NANO PEN NEEDLES 4MM (5/32) 32G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 17, 2020

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·April 22, 2020

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 6, 2013

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 21, 2011

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 23, 2013

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 23, 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