BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    iChemVELOCITY Automated Urine Chemistry System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UHEAD

    FDA UDI
    Stryker GmbH·00886385013565·Ulnar Broach Assembly; Size 3

    PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50

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

    DSS STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES, INC.·Product code LWR·July 8, 2011

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·June 14, 2013

    3M ELECTROSURGICAL PATIENT PLATE, STANDARD, NON CORDED

    FDA Adverse Event
    Injury ·3M HEALTHCARE, 3M CO.·Product code ODR·September 18, 2008

    Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

    FDA Enforcement
    Class II ·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·June 12, 2019

    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