BEUDAMED
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    Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Broach 37.5 size 2

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215055394·

    JDEVOLUTION PLUS

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·September 12, 2025

    MERCURY SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMARTLITE PS PEN-STYLE LED CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 9, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code CAW·November 10, 2014

    MAVERICK

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 22, 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