2 results
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15ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination. INDICATIONS " Management of superficial, dry to lightly exudating dermal ulcers. " Post-operative wounds. " Protective dressings.
FDA Enforcement
Class II
·Ongoing·ConvaTec, Inc·October 22, 2025