Company ยท US
Zenith Technical Innovations
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2024. 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 |
|---|---|---|---|
| Jun 21, 2024 | K240125 | Therm-X (Home); Therm-X (AT) Zenith Technical Innovations | JOW |
| Jul 27, 2023 | K231912 | Therm-X Zenith Technical Innovations | IRP |
| Feb 28, 2020 | K193550 | Therm-X Zenith Technical Innovations | IRP |
| May 10, 2019 | K190854 | Therm-X Zenith Technical Innovations | IRP |
| Aug 3, 2018 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete Zenith Technical Innovations | IRP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||