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

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    Icare ic200

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319705414·Billeau Flexible Ear Loop 6-1/2" (16.3cm), medi...

    Cadwell Guardian

    FDA UDI
    CADWELL INDUSTRIES, INC.·00840067103609·AVX Auditory and Visual Stimulator

    INFOSEND GSM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FFL·January 22, 2018

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 6, 2008

    J-VAC RESERVOIRS

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code KOG·June 26, 2013

    MELODY TRANSCATHER PULMONARY

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES, INC.·Product code NPV·July 20, 2011

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JKA·December 6, 2019

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 3, 2025

    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