BEUDAMED
    11 results · 33ms · Sources: EU EUDAMED, US FDA

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    TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GEM HEART ONE/ONE+

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOCHOICE WATER BOTTLE CAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MERGE CARDIO

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE SOLUTIONS INC.·Product code LLZ·October 20, 2023

    I-STAT E3+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 31, 2020

    ASPHERE M SPEC 12/14 36 +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·May 15, 2013

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·May 15, 2013

    UNKNOWN LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·June 27, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 5, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 22, 2014

    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