BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    The LINK® Endo-Model® Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SELECT 3D ARTERIAL CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRELUDE II TOUNGE SUSPENSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 28, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2025

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014

    PFCSIG +/-2FEMOFFSET STMBLT

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code JWH·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 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