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

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    Genie MAX Large Bore Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREEDOM RINGLOC -X +5 52/36MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWZ·November 18, 2019

    ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·August 10, 2011

    FLEXTEND IS-1 BI POSITIVE FIX

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·November 11, 2008

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 17, 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