BEUDAMED
    15 results · 36ms · 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.

    SANUWAVE, INC.

    FDA registration
    SANUWAVE, INC.·3 products·🇺🇸 United States

    UltraMIST Single Use Applicator (12 Pack)

    FDA UDI
    SANUWAVE Health, Inc.·00812265010348·UltraMIST Single Use Applicator (12 pack Carton...

    Profile Console

    FDA UDI
    SANUWAVE Health, Inc.·00812265010287·Profile provides mechanically assisted deep sof...

    Profile Applicator

    FDA UDI
    SANUWAVE Health, Inc.·00812265010300·Profile Hand-held Treatment Applicator designed...

    UltraMIST Generator

    FDA UDI
    SANUWAVE Health, Inc.·00812265010317·The UltraMIST Generator

    UltraMIST Single Use Applicator

    FDA UDI
    SANUWAVE Health, Inc.·00812265010331·Applicator fr UltraMIST (Wound Cleanser)

    dermaPACE Console

    FDA UDI
    SANUWAVE Health, Inc.·00812265010218·Energy generator and control unit ( t be used i...

    dermaPACE Applicator

    FDA UDI
    SANUWAVE Health, Inc.·00812265010201·Delivery device of Extracorporeal Shock Wave (E...

    dermaPACE System (Console with applicator)

    FDA UDI
    SANUWAVE Health, Inc.·00812265010225·The dermaPACE console and applicator shipped to...

    Profile Applicator

    FDA UDI
    SANUWAVE Health, Inc.·00812265010294·Profile Hand-held Treatment Applicator designed...

    UltraMIST Treatment Wand

    FDA UDI
    SANUWAVE Health, Inc.·00812265010324·Component to the UltraMIST System

    HEALTHTRONICS OSSATRON

    FDA Adverse Event
    Malfunction ·SANUWAVE, INC.·Product code NBN·September 25, 2007

    ULTRAMIST

    FDA Adverse Event
    Injury ·SANUWAVE, INC.·Product code NRB·May 4, 2026

    ULTRAMIST

    FDA Adverse Event
    Injury ·SANUWAVE, INC.·Product code NRB·April 30, 2026

    ULTRAMIST

    FDA Adverse Event
    Death ·SANUWAVE, INC.·Product code NRB·April 30, 2026