BEUDAMED
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    INFINITY Total Ankle System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOTEQ ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TOXCUP DRUG SCREEN CUP

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    5X10 ANGLED LOCK FRAC PLATE,LT

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·June 17, 2013

    HUDSON HEATED-WIRE VENTILATOR CIRCUIT 18" 21 V

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTT·June 23, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·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