Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 Eigen with 18 510(k) clearances. The most recent is a 510(k) clearance dated Oct 12, 2023: Artemis, Artemis TPO, Artemis MX.
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 12, 2023 | Artemis, Artemis TPO, Artemis MXK222222 · QTZ | 510(k) clearances |
| Nov 21, 2018 | ProFuse CADK173744 · LLZ | 510(k) clearances |
| Oct 21, 2016 | ArtemisK162474 · LLZ | 510(k) clearances |
| Aug 29, 2008 | DSA 2000EXK082341 · LLZ | 510(k) clearances |
| May 1, 2008 | 3-D IMAGING WORKSTATIONK081093 · LLZ | 510(k) clearances |
| Jan 26, 2007 | EIGEN DSA 2000K063846 · LLZ | 510(k) clearances |
| Apr 7, 1994 | DIGITAL DISK RECORDERK933115 · LMB | 510(k) clearances |
| Nov 23, 1992 | DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPTK924164 · JAA | 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
