Hydrogel Spacer
Regulation 892.5725
2510(k)s in 12 months (8 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OVB
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 3 | 2 |
| Augmenix, Inc. | 3 | 0 |
| Bioprotect, Ltd. | 1 | 0 |
| Palette Life Sciences | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2026 | K262151 | SpaceOAR Flex System Boston Scientific Corporation | OVB |
| Feb 10, 2026 | K260119 | SpaceOAR Vue System (SV-2101) Boston Scientific Corporation | OVB |
| Aug 25, 2023 | K222972 | BioProtect Balloon Implant System Bioprotect, Ltd., IL | OVB |
| May 26, 2022 | K220641 | Barrigel Injectable Gel Palette Life Sciences | OVB |
| Aug 28, 2020 | K202224 | SpaceOAR System Boston Scientific Corporation | OVB |
| Jul 19, 2019 | K182971 | SpaceOAR Vue Hydrogel Augmenix, Inc. | OVB |
| Jun 25, 2018 | K181465 | SpaceOAR System Augmenix, Inc. | OVB |
| Apr 1, 2015 | DEN140030 | SpaceOAR System Augmenix, Inc. | OVB |
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