BEUDAMED
    19 results · 35ms · Sources: EU EUDAMED, US FDA

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    Aesculap Slim Clip Applier

    FDA 510(k)
    FDA Class 2 ·Neurology

    TRIPLE LUMEN PFM PICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ULTRASHARP CONCENTRIC NEEDLES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·October 10, 2018

    ACCESS® VITAMIN B12

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code CDD·May 21, 2013

    ACCESS® VITAMIN B12 ASSAY

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code CDD·May 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 20, 2013

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·July 22, 2011

    INTELECT ADVANCED COMBO

    FDA Adverse Event
    Malfunction ·CHATTANOOGA GROUP·Product code IPF·September 29, 2008

    ACCESS VITAMIN B12

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code CDD·January 1, 2015

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 17, 2022

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·January 4, 2019

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 17, 2022

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 17, 2022

    DI 600 ACCESS IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·January 28, 2020

    DXI 600 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·January 28, 2020

    ACCESS VITAMIN B12 COBALAMIN

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code CDD·March 26, 2021

    DXI 600 ACCESS IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·January 28, 2020

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022