BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Agile Esophageal Stent System

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

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 20, 2025

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 30, 2025

    STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIORA V-TOTAL

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

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·August 30, 2022

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2014

    JOHNSON AND JOHNSON

    FDA Adverse Event
    Injury ·Product code DQX·July 15, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 18, 2015

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025