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

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    ADVANSET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ScannerSide DoseCheck

    FDA 510(k)
    FDA Class 2 ·Radiology

    ISOBAR SEMI-RIGID DUAL DAMPENER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERMAHAND-MERSILK SILK SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAP·April 24, 2014

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·October 3, 2012

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 15, 2008

    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