BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    Eclipse Treatment Planning System

    FDA 510(k)
    FDA Class 2 ·Radiology

    WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 7, 2017

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 14, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·June 14, 2013

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 21, 2011

    MEMORY II DOUBLE LUMEN EXTRACTION BASKET

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code LQR·July 28, 2021

    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