Not currently registered with FDA under this name
Ventus Medical, Inc.
Belmont, CA, United States. Named as applicant on 3 dental 510(k) clearances between 2008 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32008–2010
- Markets registered in
- 32 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Ventus Medical, 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 | Applicant | Ventus Medical, Inc. | 3 clearances | 2008–2010 | Below |
| Canada | Health Canada | Registration holder | VENTUS MEDICAL INC. | 1 | 2012–2012 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Ventus Medical Limited | 1 | — | 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
510(k) clearances
Clearances on which FDA names Ventus Medical, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Dec 2010 | K102404 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) | OHP Intranasal Expiratory Resistance Valve for Obstructive Sleep Apnea |
| 3 Apr 2009 | K090398 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | OHP Intranasal Expiratory Resistance Valve for Obstructive Sleep Apnea |
| 8 Feb 2008 | K071560 | PROVENT NASAL DILATOR, MODEL BR2 | OHP Intranasal Expiratory Resistance Valve for Obstructive Sleep Apnea |
Sources
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 of the most recent filing, which can be a US agent.