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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD RECYKLEEN SHARPS COLLECTORS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    HYDRATOME? RX 44

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·June 17, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 22, 2011

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·September 19, 2008

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020