BEUDAMED
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    ASD Oral Appliances

    FDA 510(k)
    FDA Class 2 ·Dental

    SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GRANDIO SO FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 6, 2023

    NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 13, 2026

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·October 10, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 11, 2013

    EON C 16-CHANNEL IPG

    FDA Adverse Event
    Other ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 9, 2011

    POLARUS® 3 PROXIMAL LOCKING NAIL 150MM L

    FDA Adverse Event
    Malfunction ·ACUMED, LLC·Product code LXH·January 8, 2025

    AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·August 19, 2015