BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    S40 CLINICAL ANALYZER, S TEST IP, S TEST UA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PEPGEN P-15 PUTTY

    FDA Adverse Event
    Injury ·DENTSPLY FRIADENT CERAMED·Product code NPZ·June 15, 2006

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 17, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·June 15, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·September 18, 2008

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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