BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    CP620G LCD monitor, CP620 LCD monitor

    FDA 510(k)
    FDA Class 2 ·Radiology

    Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCELEDENT AURA

    FDA 510(k)
    FDA Class 2 ·Dental

    I-STAT

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·April 21, 2023

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 6, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·July 16, 2013

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021