BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    DESS Dental Smart Solutions

    FDA 510(k)
    FDA Class 2 ·Dental

    Bernafon

    FDA UDI
    Bernafon AG·05711583028347·CL100 CIC, V2 BE CELEBRATE 100

    GEN4 DIRECT ACCESS

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828173599·GEN4 DIRECT ACCESS

    PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HUMAN IGA2 KIT FOR USE ON THE SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 2, 2025

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LKK·June 14, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 21, 2011

    NDI PASSIVE SPHERES

    FDA Adverse Event
    Malfunction ·NORTHERN DIGITAL, INC.·Product code HAW·July 11, 2014

    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