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

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    TiGer Shark™ System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    n/a

    FDA UDI
    Ortho Development Corporation·00822409108152·Cement Only Broach Size 16

    NIOX MINO

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/17 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 13, 2021

    FUJIFILM ENDOSCOPE MODELS EC-760R-V/M

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code FDF·March 25, 2024

    JUVEDERM VOLUMA XC 27G 2X1ML

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·October 10, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·June 17, 2013

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 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