BEUDAMED
    9 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 ×

    uMR 680

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464057412·SONIC RADIANT 40 MNR T BR/TP

    RESURFACING CAGE, 30MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSD·November 3, 2023

    ATRILAZE SOFT TISSUE ABLATION SYSTEM

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

    Instylla Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAN·September 9, 2011

    IV ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·August 21, 2008

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 22, 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