Optim
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.
- 510(k) clearances: 6
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| May 14, 2026 | ENTity USB Videoscope SystemK254133 · EOB | 510(k) clearances |
| Jan 13, 2021 | ENTity WiFi Video Nasopharyngoscope SystemK200609 · EOB | 510(k) clearances |
| Apr 19, 2013 | ELECTRODE, FLEXIBLE SUCTION COAGULATORK130489 · FEH | 510(k) clearances |
| Sep 13, 2012 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2K122593 · FEH | 510(k) clearances |
| Jul 28, 2009 | PLS PORTABLE LIGHT SOURCEK091829 · NTN | 510(k) clearances |
| Apr 2, 2008 | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105K080622 · EOB | 510(k) clearances |
Names and Identifiers
- Appears as
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