Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Omni Therm with 5 510(k) clearances. The most recent is a 510(k) clearance dated Sep 4, 1996: IMNI HOT PACKS.
| Sep 4, 1996 | IMNI HOT PACKSK955788 · IMD | 510(k) clearances |
| Sep 4, 1996 | OMNI COLD GEL PACKSK961176 · IMD | 510(k) clearances |
| Feb 13, 1996 | OMNI COLD GEL PACKSK954877 · IMD | 510(k) clearances |
| Mar 31, 1994 | OMNI WARM GEL PACKSK936084 · IMD | 510(k) clearances |
| Feb 4, 1987 | OMNI THERM TEMPERATURE MONITORK864853 · KPD | 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
