BEUDAMED
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    Cycler Drain Bag Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZEUS ELISA HSV GC-I IGG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 17, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 23, 2011

    APOGEE INTERMITTENT URINARY CATHETER

    FDA Adverse Event
    Injury ·APOGEE MEDICAL, LLC·Product code KOD·September 24, 2008

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020