BEUDAMED
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    FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464054909·HEARLINK 2030 MNR T R DG

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361029229·Ø12mm X 60mm Hybrid Fusion Screw, Gen II

    NitriTec Vinyl Glove Powder Free Blue

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MACH LED 2SC

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

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    5MM FLUTED BALL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    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