BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Lateral Spinal Truss System (LSTS) Interbody Fusion Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICROFUSE PUTTY AND MICROFUSE ST MIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    WALGREENS THIN INSULIN SYRINGES

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 7, 2022

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 15, 2014

    VTD IV MICRODRIP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·June 5, 2013

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNQ·June 22, 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