BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    FibroScan

    FDA 510(k)
    FDA Class 2 ·Radiology

    Oticon

    FDA UDI
    Oticon A/S·05707131283153·H11V2, MINIBTE 312 WL 85 STG

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100141·KRATZ-BARRAQUER HEAVY WIRE SPECULUM

    BICERA (TM) RESORBABLE BONE SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFRASCANNER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 21, 2017

    OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·September 29, 2025

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·June 6, 2013

    AUGMENTED INSERT

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 29, 2011

    ALTO

    FDA Adverse Event
    Malfunction ·ELA MEDICAL·Product code MRM·September 5, 2008

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 11, 2024

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018