BEUDAMED
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    FirstFit Surgical Kit

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    MONOFILAMENT POLYPECTOMY SNARE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE

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

    PROLIFT-SYSTEM PELVIC ANT FLOOR REPAIR

    FDA Adverse Event
    Injury ·JOHNSON AND JOHNSON·Product code FTL·September 2, 2011

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 10, 2014

    NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD .·Product code MCM·July 22, 2013

    BD LUER-LOK SYRINGE 60 ML

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 19, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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