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

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    Tyber Medical PT Interbody Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FOURSNARE VASCULAR RETRIEVAL SNARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 14, 2020

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 18, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 3, 2025

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 5, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

    ACCU-CHEK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·September 18, 2008

    PERSUADER

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·August 10, 2016

    ALINITY I B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code CDD·May 14, 2021

    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