BEUDAMED
    65 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I

    FDA 510(k)
    FDA Class 2 ·Hematology

    GLIDESHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 28, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 28, 2015

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·August 7, 2019

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 7, 2022

    GLIDESHEATH

    FDA Adverse Event
    Death ·TERUMO MEDICAL CORPORATION·Product code DYB·September 6, 2023

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 1, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 19, 2022

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·January 21, 2022

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·September 28, 2023

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 29, 2020

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 2, 2021

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 18, 2022

    SENTRANT INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code DYB·November 11, 2025

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·October 9, 2018