FDA 510(k) Applications for Medical Device Product Code "NOY"

FDA 510(k) Number Applicant Device Name Decision Date
K203276 Biocompatibles UK Ltd (part of Boston Scientific Corporation Bead Block (100 - 300╡m, 1ml), Bead Block (300 - 500╡m, 1ml), Bead Block (500 - 700╡m, 1ml), Bead Block (700 - 900╡m, 1ml), Bead Block (900 - 1200╡m, 1ml), Bead Block (100 - 300╡m, 2ml), Bead Block (300 - 500╡m, 2ml), Bead Block (500 - 700╡m, 2ml), Bead B 04/20/2021
DEN160040 Biosphere Medical S.A. Embosphere Microspheres 06/21/2017
K180102 Boston Scientific Embozene Color-Advanced Microspheres 04/19/2018
K192684 MicroVention, Inc. HydroPearl Microspheres 01/22/2020


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