BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    Babyroo TN300

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464029709·OTICON MORE 2 MINIRITE T C093

    MR PERMEABILITY

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAUFLON MULTIPURPOSE SOLUTION - NO RUB

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FOUNDATION ULTRA-CONGRUENT

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code HSH·November 7, 2008

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 1, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD .·Product code MCM·July 16, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025