Not currently registered with FDA under this name
Nightbalance BV
Den Haag, Netherlands. Named as applicant on 1 dental 510(k) clearance between 2018 and 2018. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12018–2018
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names Nightbalance BV as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Jun 2018 | K180608 | Lunoa System | MYB Cervical (for Mild Sleep Apnea) Pillow |
Some of these clearances are listed with FDA today by another company: Philips Medical Systems International BV (1).
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.