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 TELEMED with 5 510(k) clearances and 2 warning letters. The most recent is a 510(k) clearance dated Feb 11, 2022: ArtUs.
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 |
|---|---|---|
| Feb 11, 2022 | ArtUsK211248 · IYN | 510(k) clearances |
| May 24, 2019 | Warning letter: Medical DevicesCDRH | Warning letters |
| Nov 14, 2017 | Warning letter: Process validation, CAPA, Complaint handlingCDRH | Warning letters |
| Aug 10, 2017 | SmartUs EXT-1M/3MK163121 · IYN | 510(k) clearances |
| Nov 3, 2016 | MicrUsK161968 · IYO | 510(k) clearances |
| Jan 26, 2012 | LOGICSCAN 64 LOGICSCAN 128K113184 · IYN | 510(k) clearances |
| Mar 14, 2011 | ECHO BLASTERK102253 · IYO | 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
