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

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    Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MINI TIGHTROPE FT REPAIR KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SULCUS BLUE

    FDA 510(k)
    FDA Unclassified ·Unknown

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 10, 2013

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·July 15, 2011

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    CAPTURA HOT BIOPSY FORCEPS

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code KGE·December 2, 2024

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·January 19, 2021

    CUSTOM PACK CB1Q91R6 NTUH CCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code DWE·June 22, 2022

    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