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

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    FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ProForma®

    FDA UDI
    Conmed Corporation·20653405051425·ProForma® ERCP Precurved Cannula 4.50F, 190 cm,...

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981232054·Capistrano 15x13x07mm Trial with Lateral Hole

    PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907

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

    STACKED ABR FOR NAVIGATOR PRO

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEUROLINE, SUBDERMAL NEEDLE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code MUZ·April 10, 2013

    CODMAN DISP PERFORATOR

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF, INC.·Product code HBF·April 4, 2011

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    PROFORMA HF 4.5 CANN CURVED 5/BX

    FDA Adverse Event
    Malfunction ·CONMED UTICA·Product code DSA·August 26, 2021

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014