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

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    NEXXT MATRIXX System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Orthos

    FDA UDI
    ORMCO CORPORATION·00889989030556·ORTHOS CM NITI ARCH19X25UPLG PK10

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198239·AK3 PS Insert Trial Size 4, 12mm

    AXIOM FASCIAL CLOSURE SYSTEM

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

    TARGET DETACHABLE COIL

    FDA 510(k)
    FDA Class 2 ·Neurology

    PRECISION LINK

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·October 7, 2008

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 27, 2013

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·August 5, 2011

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020