BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Single-use Balloon Dilatation Catheter

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

    CURVED PEEK TETRIS SPINAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RUSCH ENDOBRONCHIAL TUBES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TEXIUM

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FMF·March 19, 2026

    LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM 9.75 CM NON US

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·November 18, 2008

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·September 9, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·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