BEUDAMED
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    Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Maxima PRO 45L

    FDA 510(k)
    FDA Class 1 ·Dental

    SOURCELINK

    FDA 510(k)
    FDA Class 2 ·Radiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 10, 2014

    PIN COLLET

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·September 2, 2011

    INNER SHAFT FOR REMOVAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code OVE·July 22, 2013

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·August 8, 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