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

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    Guided Growth Plate System Plus

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INVENDO C20 COLONOSCOPY SYSTEM

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

    NAVSTATIONIRAD EMT, VERSION 1.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022

    COVIDIEN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

    COVIDIEN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

    QUARTET

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·June 20, 2013

    ONE TOUCH LANCING DEVICE

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 27, 2011

    EARLYVUE VS30 VITALS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021

    EARLYVUE VS30 VITALS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021

    KANGAROO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026

    ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·May 16, 2018

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·LEE LABORATORIES, INC.·Product code MDB·December 20, 2023

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020