Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Revmedx Inc with 6 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Nov 12, 2025: XSTAT P15.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 12, 2025 | XSTAT P15K253290 · PGZ | 510(k) clearances |
| Aug 27, 2021 | XSTAT 30 PouchK210676 · PGZ | 510(k) clearances |
| May 18, 2018 | XSTAT 30, 1-PackK180051 · PGZ | 510(k) clearances |
| May 1, 2017 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackK170334 · PGZ | 510(k) clearances |
| Jul 28, 2016 | XSTAT-12, 3-Pack, XSTAT-12, 1-PackK161020 · PGZ | 510(k) clearances |
| Dec 7, 2015 | XSTAT 30, 3-PACK, XSTAT 30, 1-PACKK152624 · PGZ | 510(k) clearances |
| Aug 12, 2015 | XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual comprClass II · The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to | Device recalls |
| Apr 3, 2014 | XSTATDEN130016 · PGZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
