BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    Lung-CAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925019492·EAR SUCTION NEEDLE 18 GA

    Salvin Dental Specialties

    FDA UDI
    SALVIN DENTAL SPECIALTIES, LLC·00841336120891·Wide Extraction Screw For Benex Pro Atraumatic ...

    CARDIUS-1 AND CARDIS-2

    FDA 510(k)
    FDA Class 2 ·Radiology

    NOVA Patient Warming System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LXG·January 26, 2023

    FG 6301 DUAL CHNL VOL INF PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 17, 2008

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·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

    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 24, 2024