BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    EnSite™ X EP System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981309947·Trial Rasp, 39mm x 30mm x 14mm, 15 Deg

    3D Printed Interbody Systems

    FDA UDI
    Seaspine Orthopedics Corporation·10889981304065·2-Hole No-Profile Interbody, 39mm x 30mm x 14mm...

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981215637·No-Profile Interbody, 39mm x 30mm x 14mm, 15 Deg

    K231485

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·October 25, 2025

    LIVE VIEW PANEL (LVP)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Vial2Bag Advanced 20mm Admixture Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981331085·Lollipop Trial, Anterior-Angled, 23mm x 14mm x ...

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981441517·Lollipop Trial 23mm x 14mm x 55mm, 15°

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

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

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    LAMITRODE S4

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code MEA·July 3, 2023

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code MEA·July 3, 2023

    FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·November 17, 2021