BEUDAMED
    7 results · 32ms · Sources: EU EUDAMED, US FDA

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    EzDent-i / E2 / Prora View

    FDA 510(k)
    FDA Class 2 ·Radiology

    NYDIAG 200

    FDA 510(k)
    FDA Unclassified ·Unknown

    PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    URETEX SUP URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·April 19, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 23, 2011

    HYDRA JAGWIRE GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FDE·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