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

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    Arthrex Knotless Mini TightRopes

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

    PILOT TUBE REPAIR KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACQPLAN 5.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·June 22, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·December 23, 2025

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026

    AVOSET INFUSION PUMP ROW

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·April 29, 2026

    MICROAIRE

    FDA Adverse Event
    Malfunction ·MICROAIRE SURGICAL INSTRUMENTS·Product code HWC·September 26, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·August 16, 2011

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    MEGASOFT UNIVERSAL

    FDA Adverse Event
    Injury ·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·January 6, 2023

    ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019