BEUDAMED
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    ALARIS PUMP MODULE

    FDA Adverse Event
    Injury ·CAREFUSION·Product code FRN·October 7, 2016

    Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images.

    FDA Recall
    Terminated ·Brainreader ApS Emil Mollers Gade 41 REGION Horsens Denmark·Product code LLZ·December 14, 2020

    SYNCHROMED II

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·August 3, 2015

    CERTAS PLUS

    FDA Adverse Event
    Death ·CODMAN & SHURTLEFF·Product code JXG·August 19, 2015

    PULMONETIC

    FDA Adverse Event
    Death ·PULMONETIC SYSTEMS, INC.·Product code CBK·July 26, 2006

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM

    FDA Adverse Event
    DYMAX CORP. -2523003·Product code DWJ·October 19, 2015

    LVIS INTRALUMINAL SUPPORT

    FDA Adverse Event
    Death ·MICROVENTION, INC.·Product code NJE·February 13, 2015

    *

    FDA Adverse Event
    Death ·*·Product code LTA·May 2, 1997

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - MEDINA·Product code FRN·January 3, 2019

    CENTRIMAG BLOOD PUMP

    FDA Adverse Event
    Injury ·THORATEC SWITZERLAND GMBH·Product code KFM·April 27, 2021

    WINGSPAN STENT

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - FREMONT·Product code NJE·June 10, 2010

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·February 13, 2017

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·October 24, 2022

    ALARIS SYSTEM

    FDA Adverse Event
    Death ·CAREFUSION SD·Product code FRN·November 22, 2022

    LVIS JR 3.5X23MM

    FDA Adverse Event
    Death ·MICROVENTION, INC.·Product code NJE·November 21, 2018

    NELLCOR

    FDA Adverse Event
    Death ·COVIDIEN LLC·Product code DQA·August 4, 2025

    ILS 25MM, CURVED

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 16, 2018

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·April 10, 2014

    EVERA MRI XT DR SURESCAN

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LWS·February 11, 2026

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 13, 2016