BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    IV Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MUSCLE PAIN DEVICE (MPD)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SECURIS SPINAL FIXATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 7, 2025

    EKOSONIC ENDOVASCULAR DEVICE, 106X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 15, 2014

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 17, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE ? MOUNTAIN HOME·Product code FKX·July 23, 2011

    SENSITHERM PROBE

    FDA Adverse Event
    Injury ·FIAB S.P.A.·Product code FLL·July 10, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    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