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

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    Neodent Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    INOMAX DS (DELIVERY SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 21, 2014

    POLIGRIP

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·June 21, 2013

    ULTRAFLOW HPC 1.5F

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code DYG·August 4, 2011

    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