BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Versus™ Catheter (VS110-8B)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXULT Femoral component trial - Left, EXULT Femoral component trial - Right

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NAVILAS LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PORTEX® SPINAL ANESTHESIA TRAYS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code CAZ·May 11, 2018

    PRECISION SPECTRA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 10, 2014

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 9, 2011

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 22, 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