BEUDAMED
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    Handbike Batec Electric

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    KONUS DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    JMS ABSORBABLE ANCHOR AND APPLICATOR

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

    WALLFLEX DUODENAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·November 20, 2008

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·CIVIDIEN, FORMERLY NELLCOR·Product code CBK·August 17, 2011

    TI MULTI VECTOR DISTRACTOR ARM15MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code DZL·July 22, 2013

    WALLFLEX COLONIC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 18, 2024

    WALLFLEX COLONIC

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 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

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020