Panels › Gastroenterology, Urology › Product code NOY · Class 2
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Regulation 876.5550
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NOY
| Company | 510(k)s | Recalls |
|---|---|---|
| MicroVention, Inc. | 1 | 1 |
| Biocompatibles UK Ltd (Part of Boston Scientific Corporation | 1 | 0 |
| Biosphere Medical, S.A. | 1 | 0 |
| Boston Scientific | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 20, 2021 | K203276 | Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1m Biocompatibles UK Ltd (Part of Boston Scientific Corporation, GB | NOY |
| Jan 22, 2020 | K192684 | HydroPearl Microspheres MicroVention, Inc. | NOY |
| Apr 19, 2018 | K180102 | Embozene Color-Advanced Microspheres Boston Scientific | NOY |
| Jun 21, 2017 | DEN160040 | Embosphere Microspheres Biosphere Medical, S.A., FR | NOY |
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