BEUDAMED
    11 results · 37ms · 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.

    REVMEDX, INC.

    FDA registration
    REVMEDX, INC.·4 products·🇺🇸 United States

    XSTAT P30

    FDA UDI
    Revmedx, Inc.·00851587006226·Hemostatic device for severe bleeding. Each de...

    XSTAT

    FDA UDI
    Revmedx, Inc.·00851587006042·A hemostatic device for severe bleeding. Each d...

    XGAUZE Trauma Pad

    FDA UDI
    Revmedx, Inc.·00851587006073·XGAUZE Trauma Pad Sterile Wound Dressing

    AirWrap

    FDA UDI
    Revmedx, Inc.·00851587006080·Pressure bandage

    XSTAT

    FDA UDI
    Revmedx, Inc.·00851587006059·A hemostatic device for severe bleeding. Each d...

    XSTAT

    FDA UDI
    Revmedx, Inc.·00851587006066·A hemostatic device for severe bleeding. Each d...

    AirWrap XL

    FDA UDI
    Revmedx, Inc.·00851587006097·AirWrap XL

    RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code NAB·November 5, 2020

    XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.

    FDA Recall
    Terminated ·Revmedx Inc·Product code NAB·August 12, 2015

    XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.

    FDA Enforcement
    Class II ·Terminated·Revmedx Inc·September 23, 2015