BEUDAMED
    10 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 ×

    dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T

    FDA 510(k)
    FDA Class 2 ·Radiology

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 7, 2010

    CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RAD-G

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024

    TRUMATCH CT CUT GUIDE KIT R

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code OOG·December 19, 2023

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 22, 2008

    SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHR·August 17, 2011

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code OTN·July 3, 2013

    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