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

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    ARIX Femur Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NoCord

    FDA 510(k)
    FDA Class 2 ·Dental

    QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PUMP MMT-712RNAP PRDGM INS PL EN US RC

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·December 4, 2008

    CRURASOFT PATCH

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·September 12, 2011

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·July 29, 2013

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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