BEUDAMED
    3 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Iii × Clear all

    Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.

    FDA Enforcement
    Class III ·Terminated·Coloplast Manufacturing US, LLC·November 5, 2014

    Regard Custom Procedure Kits containing BD Luer Lok Access Devices

    FDA Enforcement
    Class III ·Terminated·ROi CPS LLC·April 6, 2022

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    FDA Enforcement
    Class III ·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·September 21, 2022