BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VOLUSON S6, VOLUSON S8

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARDIUS 3 X-ACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    BEND-SCR F/UNILOCK-RECOPL TI

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·June 22, 2013

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·July 29, 2011

    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