BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    ScopeFlow Pure(TM)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361800·Integra® Miltex® Iris Scissors, 3-3/4", Curved,...

    STAXX(R) XD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPINAL ELEMENTS BUTTRESS PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 25, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 17, 2014

    LEAD MODEL UNKNOWN

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 6, 2011

    LOFRIC

    FDA Adverse Event
    Injury ·WELLSPECT HEALTHCARE·Product code KOD·June 14, 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