BEUDAMED
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    Arthrosurface Bone Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICRODOT & MICRODOT XTRA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HABIB ENDOBLATE

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

    RELION® INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 20, 2022

    HOMEPUMP C-SERIES: 270 ML, 5 ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW, LLC.·Product code MEB·June 5, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 17, 2011

    ROTALINK PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code MCX·September 19, 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