BEUDAMED
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    Contour Shoulder

    FDA 510(k)
    FDA Class 2 ·Radiology

    Non-Contact Forehead Thermometer (UT30H)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    PARADIGM QUICKSERTER

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code KZH·November 6, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 2, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013

    Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·February 14, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025