BEUDAMED
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    Monaco RTP System

    FDA 510(k)
    FDA Class 2 ·Radiology

    DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    NYCOCARD CRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

    SYNERGY

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO. MED REL·Product code LGW·October 22, 2008

    HAI MEDIC

    FDA Adverse Event
    Malfunction ·Product code JWH·June 26, 2007

    TEGRESS URETHRAL IMPLANT

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code LNM·July 3, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019