BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    Arthrex Synergy Vision Endoscopic Imaging System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LCP

    FDA UDI
    Synthes GmbH·10886982166876·LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES...

    RANDOX TRI LEVEL CARDIAC CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PNEUMOCLEAR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code CAW·November 10, 2014

    INSTATRAK 3500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·August 17, 2011

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·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