BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    INTERACOUSTICS EP 15 ABR STAND ALONE UNIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    Dual-Safety Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INVISION-PLUS

    FDA Adverse Event
    Malfunction ·RYMED TECHNOLOGIES, LLC·Product code FPA·July 7, 2022

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 6, 2013

    SIGMA 300 SR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·February 15, 2011

    OT VERIO PRO PLUS METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 8, 2014

    ULTRACLEAN ELECTRODE 1"BLADE EXTENDED INSULATION

    FDA Adverse Event
    Malfunction ·CONSOLIDATED MEDICAL EQUIPMENT·Product code GEI·January 3, 2020

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; 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 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