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 13, 2026, FDA's public records list Remedi with 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 2, 2026: REMEX-T(K)100C.
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.
| Date | Record | Source |
|---|---|---|
| Oct 2, 2026 | REMEX-T(K)100CK261943 · IZL | 510(k) clearances |
| Jul 31, 2025 | REMEX Xcam6K250597 · IZL | 510(k) clearances |
| May 13, 2024 | REMEX-GR100K240759 · EHD | 510(k) clearances |
| Aug 3, 2021 | Remex KA6K212144 · IZL | 510(k) clearances |
| Feb 28, 2020 | R-Sensor, R-SensorK200284 · MUH | 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
