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

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    Ingenia Elition S and Ingenia Elition X R5.4

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRUITT CAROTID KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 22, 2022

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 30, 2026

    32MM MOD HEAD COCR STD NECK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·October 15, 2014

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/20MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·June 17, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 23, 2011

    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