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

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    Arthrex Virtual Implant Positioning (VIP) System Software

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYRINGE 3ML LL W/NDL 21X1 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·December 5, 2023

    CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE

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

    Banyan USA Surgical Mask Level 3

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

    ECHELON 45 ENDOPATH STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC·Product code GDW·November 21, 2008

    C-FLEX ASPHERIC

    FDA Adverse Event
    Malfunction ·RAYNER INTRAOCULAR LENSES LTD.·Product code HQL·August 16, 2011

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·July 18, 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