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

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    LORRAINE 2.5/3.5mm Distal Humerus System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    iBond Universal & iBond Ceramic Primer

    FDA 510(k)
    FDA Class 2 ·Dental

    FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 7, 2022

    QT SCANNER 2000 MODEL A

    FDA Adverse Event
    Injury ·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025

    ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·June 30, 2014

    PARADYM

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code MRM·November 14, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011

    CONFIRM

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code MXC·July 29, 2013

    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