A comprehensive view of FDA 510(k) Clearance. This page highlights a small sample of our full coverage.
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Ahlstrom receives FDA 510(k) clearance for Reliance Fusion sterilization wrap for surgical equipment trays at hospitals; wrap is made of cellulose-based and PP-based materials, allows a significant reduction in drying time, leads to increased efficiency

BD receives FDA 510(k) clearance for BD MiniDraw capillary blood collection system; system enables lab-quality blood testing from less invasive method than venous collection in more convenient locations

West receives FDA 510(k) clearance for Vial2Bag Advanced 13mm admixture device; the needle-free device has a dual channel design to provide dedicated fluid pathways into and out of an IV bag and a robust vial spike design for connection to the drug vial

Exactech announces FDA 510k) clearance for its Activit-E PE used in the Vantage Total Ankle System medical implant; material includes vitamin E antioxidant stabilization for long-term performance, company says

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