BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    ORTHOLOC(TM) BONE SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CTS-485 ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TRAPEASE FILTER

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code DTK·June 3, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 14, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    ACHIEVE MAPPING CATHETER - 20 MM

    FDA Adverse Event
    Death ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DRF·April 15, 2024

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Death ·MEDTRONIC CRYOCATH LP·Product code OAE·April 15, 2024

    CARDIOSAVE HYBRID

    FDA Adverse Event
    Injury ·DATASCOPE CORP. - MAHWAH·Product code DSP·June 11, 2020

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·July 25, 2018

    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·January 16, 2013

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025