BEUDAMED
    8 results · 18ms · 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.

    Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Mercu 1717V

    FDA 510(k)
    FDA Class 2 ·Radiology

    Broncoflex Agile, Broncoflex Vortex, Screeni

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GYNECARE TVT OBTURATOR

    FDA Adverse Event
    Injury ·CALDERA MEDICAL INC.·Product code OTN·October 28, 2025

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 11, 2014

    LCS COMP RP INSERT STD+ 10MM

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code NJL·September 19, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code IKX·July 29, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014