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

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    RIVAL View Plating Systems and Reduce Fracture Plating Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLACARE DENTAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DISCARDIT II 2 ML WITH 25G X 1

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·December 16, 2019

    TRANSCEND 365 MINICPAP SYSTEM

    FDA Adverse Event
    Injury ·SOMNETICS INTERNATIONAL, INC.·Product code BZD·October 6, 2021

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LZG·October 21, 2014

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 21, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 28, 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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024