BEUDAMED
    7 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.

    Harmony Referral System with Harmony OCT Viewer (Octave)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Comfort Gown, Safewear Gown

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

    Infrared Heat (Model: E0221)

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

    COGNIS HE IS-1/DF-1/IS-1

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008

    CLARION

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC.·Product code MCM·September 12, 2011

    VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 23, 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