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510(k) Data Aggregation

    K Number
    K232655
    Device Name
    Bonvadis®
    Manufacturer
    StemCyte Inc.
    Date Cleared
    2024-05-22

    (265 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    StemCyte Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the direction of a healthcare professional, the Rx product is indicated for the management of partial thickness wounds, closed post-surgical wounds, and 1st and superficial 2nd degree burns.
    Device Description
    Bonvadis® is a non-sterile water based, preserved, semi-viscous formulation, for prescription use. Bonvadis® contains methyl and propyl parabens which act as preservatives to inhibit the growth of microorganisms within the product before opening and between uses. Bonvadis® is multiple use and supplied in a 15 g aluminum tube. The formulation is to maintain a moist wound environment, the moist wound environment being conducive for wound healing. Ingredients: Purified water, liquid petrolatum, white petrolatum, propylene glycol, cetyl stearyl alcohol, span 60, tween 60, Centella Asiatica extract, Mexican Mint extract, Methyl Paraben, and Propyl Paraben.
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    K Number
    K212554
    Device Name
    Bonvadis Topical Cream
    Manufacturer
    StemCyte Inc.
    Date Cleared
    2022-08-19

    (371 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    StemCyte Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bonvadis Topical Cream is indicated for the management of minor skin lacerations, cuts, and minor burns.
    Device Description
    Not Found
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