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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Veloxion System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120663·Guidewire 2.0x230mm Sgl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120656·Guidewire 2.0x230mm Drill Tip

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776182687·RONGEUR BEYER CVD DOUBLE ACTION

    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

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120670·Guide wire, 2.0x230mm Pt.Thrd.

    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

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·January 8, 2026

    CONSENSUS UNIPOLAR HEAD, COCR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·September 8, 2021

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·September 20, 2023

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HTW·July 25, 2023

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·August 11, 2025

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HTW·April 27, 2023

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·October 17, 2022

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMNI LIFE SCIENCE, INC.·Product code KWY·October 7, 2008

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·January 4, 2023

    DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE F/

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·January 28, 2025

    DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE F/

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·July 7, 2023