BEUDAMED
    22 results · 33ms · Sources: EU EUDAMED, US FDA

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    e-Celsius Medical System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VIDAS SARS-COV-2 IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·March 2, 2021

    VIDAS SARS-COV-2 IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·February 9, 2021

    VIDAS SARS-COV-2 IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·February 9, 2021

    VIDAS SARS-COV-2 IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·March 2, 2021

    VIDAS SARS-COV-2 IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·March 2, 2021

    MODIFICATION TO PLUM XL INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 16, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    BAB FLEXIBLE FABRIC BANDAGES

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·April 25, 2022

    MEDTRONIC

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code LGW·October 23, 2008

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·August 12, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

    VIDAS SARS-COV-2 IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·December 30, 2020

    BAND AID CLEAR BANDAGES

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·February 23, 2023

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 2, 2023

    VIDAS SARS-COV-2 IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·March 24, 2021

    AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

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