Company ยท US
Omni Therm, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1996. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 1996 | K961176 | OMNI COLD GEL PACKS Omni Therm, Inc. | IMD |
| Sep 4, 1996 | K955788 | IMNI HOT PACKS Omni Therm, Inc. | IMD |
| Feb 13, 1996 | K954877 | OMNI COLD GEL PACKS Omni Therm, Inc. | IMD |
| Mar 31, 1994 | K936084 | OMNI WARM GEL PACKS Omni Therm, Inc. | IMD |
| Feb 4, 1987 | K864853 | OMNI THERM TEMPERATURE MONITOR Omni Therm, Inc. | KPD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||