Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Radmedix with 6 510(k) clearances. The most recent is a 510(k) clearance dated Oct 25, 2023: AcuityUDR.
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.
| Oct 25, 2023 | AcuityUDRK231995 · KPR | 510(k) clearances |
| Jul 12, 2023 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4K231709 · MQB | 510(k) clearances |
| Apr 30, 2021 | AcuityDReK210919 · MQB | 510(k) clearances |
| May 6, 2020 | Accuvue+K201058 · MQB | 510(k) clearances |
| Apr 13, 2020 | AcuityPDRK200726 · IZL | 510(k) clearances |
| Jan 2, 2020 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardK193360 · KPR | 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
