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

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    Tyvek Sterilization Pouches with Chevron Seal

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROSIM 4, PROSIM 6, PROSIM 8

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER

    FDA 510(k)
    FDA Unclassified ·Unknown

    PRESIDIO 10 CERE 5MMX17CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·December 28, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+3MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 6, 2020

    ENDOPATH** ETS45

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 20, 2011

    NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR6-10

    FDA Adverse Event
    Injury ·ZIMMER TRABECULAR METAL TECHNOLOGY·Product code JWH·June 10, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 14, 2014

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSD·April 14, 2026

    REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·March 23, 2018

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·January 23, 2026

    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