Manufacturer registered with FDA
Innomed Healthscience, Inc.
Deerfield Bch, FL, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 12018–2018
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Innomed Healthscience, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Innomed Healthscience, Inc. | 1 clearances | 2018–2018 | Below |
| Australia | TGA | Manufacturer | Innomed Healthscience Inc | 1 | 2021–2021 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Innomed Healthscience, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intranasal Expiratory Resistance Valve for Obstructive Sleep ApneaOHP · Class 2 | — | Maker | Bongo RX | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INNOMED HEALTHSCIENCE, INC.FDA reg. 3014941496 | Deerfield Bch, FL, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058909). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.