BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    DUO TWO LAYER DENTURE CLEANSER

    FDA 510(k)
    FDA Class 1 ·Dental

    Continuum® Trilogy®

    FDA UDI
    Zimmer, Inc.·00889024152625·

    Argon Handset

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NAVILAS LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ATLAS II PLUS DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 5, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 15, 2012

    INSYNC SENTRY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 10, 2010

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    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