BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 21, 2010

    LEAD MODEL 304

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·February 4, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEATHCARE CORPORATION·Product code KDJ·July 17, 2014

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025

    OT SURESTEP METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 6, 2010

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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