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

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    Yxoss CBR®

    FDA 510(k)
    FDA Class 2 ·Dental

    PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL

    FDA 510(k)
    FDA Class 2 ·Radiology

    VISUM BLADE LED SURGICAL LIGHTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FUJIFILM DUODENOSCOPE MODEL ED-580T

    FDA Adverse Event
    Injury ·FUJIFILM CORPORATION·Product code FDT·September 5, 2023

    FUJIFILM ENDOSCOPE

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code FDS·March 18, 2022

    FUJIFILM DUODENOSCOPE ED-580T

    FDA Adverse Event
    Injury ·FUJIFILM CORPORATION·Product code FDT·March 5, 2025

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 27, 2013

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 22, 2014

    LEICA BOND-MAX

    FDA Adverse Event
    Malfunction ·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·June 16, 2011

    VAXCEL PICC

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LJS·September 13, 2007

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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