BEUDAMED
    1,478 results · 45ms · Sources: EU EUDAMED, US FDA

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    Insulin Insights™

    FDA UDI
    MELLITUS HEALTH, INC.·00860001009804·Insulin Insights™ is a glycemic management soft...

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·September 23, 2020

    NOVOPEN 3 (INSULIN DELIVERY DEVICE) N/A

    FDA Adverse Event
    Other ·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·November 2, 2010

    NOVOFINE 8MM (30G) AUTOCOVER

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S - MS HJOERRING·Product code FMI·September 21, 2011

    NOVOFINE

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S -·Product code FMF·June 30, 2014

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 15, 2022

    SUPER POLIGRIP

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOP·December 9, 2004

    FORTIFY ASSURA VR ICD, US

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWS·August 29, 2017

    NOVOFINE 32G 6 MM

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S·Product code FMI·November 24, 2022

    PRELUDE IDEAL

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DYB·April 1, 2021

    FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

    FDA Enforcement
    Class I ·Terminated·Abbott Diabetes Care, Inc.·December 25, 2013

    NOVOPEN 4

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·July 10, 2019

    ASSURITY MRI

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code DXY·October 8, 2018

    NOVOFINE (30G)

    FDA Adverse Event
    Other ·NOVO NORDISK A/S MEDICAL SYSTEMS·Product code FMF·February 21, 2013

    BIWAZE

    FDA Adverse Event
    Malfunction ·ABMRC LLC·Product code NHJ·October 22, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 5, 2025

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·February 14, 2018

    NOVOFINE (32G) (NEEDLE) NA

    FDA Adverse Event
    Other ·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMI·April 7, 2011

    NOVOPEN 5

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S·Product code FMF·December 28, 2020

    TENDRIL STS

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·January 6, 2016