Panels › General, Plastic Surgery › Product code PGZ · Class 2
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Regulation 878.4452
1510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PGZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Revmedx, Inc. | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 12, 2025 | K253290 | XSTAT P15 Revmedx, Inc. | PGZ |
| Aug 27, 2021 | K210676 | XSTAT 30 Pouch Revmedx, Inc. | PGZ |
| May 18, 2018 | K180051 | XSTAT 30, 1-Pack Revmedx, Inc. | PGZ |
| May 1, 2017 | K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack Revmedx, Inc. | PGZ |
| Jul 28, 2016 | K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack Revmedx, Inc. | PGZ |
| Dec 7, 2015 | K152624 | XSTAT 30, 3-PACK, XSTAT 30, 1-PACK Revmedx, Inc. | PGZ |
| Apr 3, 2014 | DEN130016 | XSTAT Revmedx, Inc. | PGZ |
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