BEUDAMED
    23 results · 23ms · Sources: EU EUDAMED, US FDA

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    QLAB Advanced Quantification Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771052330·K-Wires, Single trocar, Threaded, .062-inch (1....

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293371·

    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

    INTEGRAL X-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304650435·

    ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM

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

    SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANIX BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 8, 2025

    ADVANIX BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 5, 2024

    ADVANIX BILIARY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 30, 2024

    EDWARDS EXPANDABLE INTRODUCER SET, 23MM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 14, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 22, 2008

    ADVANIX? BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·October 30, 2025

    ARCHITECT B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·April 17, 2025

    ADVANIX BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 21, 2025

    ALINITY I B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·January 27, 2025

    ADVANIX BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·February 4, 2025

    M2A-MAGNUM MOD HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·July 17, 2019

    M2A-MAGNUM PF CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 17, 2019