Manufacturer registered with FDA
Ondine Biomedical Inc.
Bothell, WA, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 666 registrations outside the US
- Establishments
- 1United States
Registered in 6 markets
Where regulators' registries name Ondine Biomedical 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 | Ondine Biomedical Inc. | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | ONDINE BIOMEDICAL INC. | 56 | 2005–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Ondine Biomedical Inc | 3 | 2017–2017 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Ondine Biomedical Inc. | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Ondine Biomedical Inc. | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Ondine Biomedical Inc. | 1 | 2012–2012 | 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 Ondine Biomedical 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 |
|---|---|---|---|---|
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Periowave 1ml photosensitizer | 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 |
|---|---|---|
| ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US)FDA reg. 3006845489 | Bothell, WA, United States | Complaint file establishment, Manufacturer, Repacker / relabeler |
Other names on FDA records
Ondine Research Laboratories/Ondine Biomedical Inc. (US)
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049666). 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.