BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    LACERATION TRAY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G7 HI-WALL E1 LINER 32MM C

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·February 22, 2023

    ENTRAK 2500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 7, 2014

    NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·February 15, 2013

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·December 22, 2010

    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