BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    DELTA PUNCTUM PLUG

    FDA 510(k)
    FDA Unclassified ·Unknown

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    FDA UDI
    Conmed Corporation·30653405033770·SELECT ONE LAPAROSCOPIC PROCEDURE PACK

    HARRISON HAND HELD ADJUSTING INSTRUMENT

    FDA 510(k)
    FDA Unclassified ·Unknown

    PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NIM·September 11, 2006

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 10, 2013

    RIATA ACTIVE FIXATION LEAD

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

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·April 4, 2011

    BD¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 14, 2018

    BACT/ALERT® FA PLUS CULTURE BOTTLE

    FDA Adverse Event
    Malfunction ·BIOMERIEUX INC.·Product code MDB·October 10, 2018

    BD¿ SYRINGE WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 19, 2018

    BD DISCARDIT¿ II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 16, 2018

    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