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

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    i-STAT CHEM8+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 25, 2023

    CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM

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

    CONNECTA WHT 360DEG TB 25CM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·February 25, 2021

    BD SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 14, 2019

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code JGS·July 22, 2011

    VANGUARD PS TIBIAL BEARING 10X71/75

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·June 22, 2013

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024

    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