Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Magentiq Eye with 4 510(k) clearances and 4 AI-enabled devices. The most recent is a 510(k) clearance dated Apr 3, 2026: MAGENTIQ-COLO (ME-APDS).
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.
| Apr 3, 2026 | MAGENTIQ-COLO (ME-APDS)K260724 · QNP | 510(k) clearances |
| Apr 3, 2026 | MAGENTIQ-COLO (ME-APDS)K260724 · Gastroenterology-Urology | AI-enabled devices |
| Oct 3, 2025 | MAGENTIQ-COLO (ME-APDS)K252178 · QNP | 510(k) clearances |
| Oct 3, 2025 | MAGENTIQ-COLO (ME-APDS)K252178 · Gastroenterology-Urology | AI-enabled devices |
| Jan 24, 2025 | MAGENTIQ-COLO (ME-APDS)K244023 · QNP | 510(k) clearances |
| Jan 24, 2025 | MAGENTIQ-COLO (ME-APDS)K244023 · Gastroenterology-Urology | AI-enabled devices |
| Jul 25, 2023 | ME-APDS™; MAGENTIQ-COLO™K223473 · QNP | 510(k) clearances |
| Jul 25, 2023 | ME-APDS; MAGENTIQ-COLOK223473 · Gastroenterology-Urology | AI-enabled devices |
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
