BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221049902·Unitek(TM) Permachrome Resilient Stainless Stee...

    ProFound AI Software V3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 19, 2011

    VITALITY AVT FAST-CHARGE

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

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 30, 2013

    H/S CATHETER 5FR STYLET

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code LKF·May 31, 2019

    H/S CATHETER 5FR STYLET

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code LKF·May 31, 2019

    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