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

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    VARIOUS TYPES OF ENT ELEVATORS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    OVERTUBE ENDOSCOPIC ACCESS SYSTEM

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

    MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA

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

    BIOSOFT DUO DOUBLE LOOP URETERAL STENT KIT

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FAD·September 26, 2024

    BIOSOFT DUO DOUBLE LOOP URETERAL STENT KIT

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FAD·September 26, 2024

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·May 20, 2014

    PULSAR GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 5, 2015

    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