Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled 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 Imedicom with 7 510(k) clearances. The most recent is a 510(k) clearance dated Apr 6, 2019: MEDINAUT Plus.
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 |
|---|---|---|
| Apr 6, 2019 | MEDINAUT PlusK182287 · HRX | 510(k) clearances |
| Aug 24, 2018 | EPINAUTK173541 · BSO | 510(k) clearances |
| Jul 29, 2016 | MEDINAUT Kyphoplasty SystemK153296 · NDN | 510(k) clearances |
| Mar 18, 2016 | SPINAUT-PK150915 · GEI | 510(k) clearances |
| Mar 16, 2016 | SPINAUT-V, SPINAUT-S, SPINAUT-IK151268 · HRX | 510(k) clearances |
| Mar 1, 2016 | SPINAUT-E, SPINAUT-IK150789 · BSO | 510(k) clearances |
| Apr 4, 2014 | MEDINAUT KYPHOPLASTY SYSTEMK133669 · NDN | 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
