BEUDAMED
    15 results · 32ms · Sources: EU EUDAMED, US FDA

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    Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left

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

    MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40

    FDA 510(k)
    FDA Class 2 ·Neurology

    AMPLATZER DUCT OCCLUDER

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL CATD·Product code MAE·July 30, 2019

    AMPLATZER VASCULAR PLUG II

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code KRD·June 27, 2018

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013

    UNKNOWN DEPUY MARK II ELBOW

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDC·July 19, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·September 19, 2008

    ALINITY S HTLV I/II REAGENT KIT

    FDA Adverse Event
    Injury ·ABBOTT GMBH·Product code QHM·September 29, 2022

    ALINITY S HTLV I/II REAGENT KIT

    FDA Adverse Event
    Injury ·ABBOTT GMBH·Product code QHM·September 29, 2022

    ALINITY S HTLV I/II REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code QHM·September 29, 2022

    ALINITY S HTLV I/II REAGENT KIT

    FDA Adverse Event
    Injury ·ABBOTT GMBH·Product code QHM·September 29, 2022

    ALINITY S HTLV I/II REAGENT KIT

    FDA Adverse Event
    Injury ·ABBOTT GMBH·Product code QHM·September 29, 2022

    ALINITY S HTLV I/II REAGENT KIT

    FDA Adverse Event
    Injury ·ABBOTT GMBH·Product code QHM·September 29, 2022

    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