BEUDAMED
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    Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)

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

    Trocar

    FDA UDI
    SOPRO-COMEG GmbH·04059082032931·

    LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WestTec Procedure Facemask;WestTec Surgical Facemask

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    GORE PROPATEN VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·November 21, 2008

    SUPERA BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·August 17, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·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