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 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Oasis Medical with 17 510(k) clearances, 7 drug recalls and 1 warning letter. The most recent is a warning letter dated Jul 15, 2025: Warning letter: Sterility assurance, Process validation, Method validation.
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.
| Jul 15, 2025 | Warning letter: Sterility assurance, Process validation, Method validationCDER | Warning letters |
| Jun 3, 2022 | SOFT PLUG Extended Duration 180 Tapered Canalicular PlugK213988 · LZU | 510(k) clearances |
| Apr 17, 2017 | Soft Plug Extended Duration 180 Canalicular PlugK162361 · LZU | 510(k) clearances |
| May 14, 2014 | Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 Class III · Labeling: Missing Label; The label on the immediate bottle is missing. | Drug recalls |
| Aug 26, 2003 | DISPOSABLE N-PE MICKROKERATOME BLADESK032297 · HNO | 510(k) clearances |
| Jun 19, 2003 | DISPOSABLE M2-PE MICROKERATOME BLADESK030401 · HNO | 510(k) clearances |
| Oct 3, 2002 | DISPOSABLE N-PE MICROKERATOME BLADESK022205 · HNO | 510(k) clearances |
| Jun 27, 2002 | SOFT PLUG ABSORBABLE PLUG-SAK013613 · LZU | 510(k) clearances |
| Mar 8, 2001 | DISPOSABLE CB-PE MICROKERATOME BLADESK003820 · HNO | 510(k) clearances |
| Sep 21, 2000 | DISPOSABLE MICROKERATOME BLADES-PEK001176 · HNO | 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
