Company ยท US
Revmedx, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| 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 |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2015 | Revmedx Inc XGAUZE Trauma Dressing, catalog number FIN-0002-01.
XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, t Terminated |
NAB | None listed |