BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Neurology

    Oticon

    FDA UDI
    Oticon A/S·05707131305459·SENSEI, BTE 13 WL 90 AQM TAR

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·September 30, 2021

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·September 30, 2021

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·September 30, 2021

    AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ENSITE VERISMO SEGMENTATION TOOL V.2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·December 23, 2024

    UNKNOWN SAPPHIRE PUMP

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·August 6, 2025

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Injury ·EITAN MEDICAL LTD.·Product code FRN·March 17, 2026

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·May 26, 2026

    UNKNOWN SAPPHIRE PUMP

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·February 2, 2026

    SAPPHIRE M.T INFUSION PUMP - GERMAN

    FDA Adverse Event
    Death ·EITAN MEDICAL LTD.·Product code FRN·April 28, 2025

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 24, 2025

    M SERIES

    FDA Adverse Event
    Death ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 31, 2013

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·July 14, 2011

    SECURA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021