BEUDAMED
    8 results · 38ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    SpectraWAVE, Inc.

    Manufacturer
    🇺🇸 United States

    SPECTRAWAVE, INC.

    FDA registration
    SPECTRAWAVE, INC.·6 products·🇺🇸 United States

    Starlight Imaging Catheter

    FDA UDI
    Spectrawave, Inc.·00860008045508·The SpectraWAVE Imaging System is an intravascu...

    HyperVue Imaging System

    FDA UDI
    Spectrawave, Inc.·00860008045515·The SpectraWAVE Imaging System is an intravascu...

    STARLIGHT IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·SPECTRAWAVE, INC.·Product code IYO·November 19, 2025

    STARLIGHT IMAGING CATHETER

    FDA Adverse Event
    Injury ·SPECTRAWAVE, INC·Product code NQQ·May 9, 2025

    Donawa Lifescience Consulting Srl

    Authorized representative
    🇮🇹 Italy·31 Manufacturers·15 Devices

    VITEK MS INSTRUMENT - 410895

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX, SA·Product code QBN·May 7, 2021