Manufacturer registered with FDA
Advanced Brain Monitoring, Inc.
Carlsbad, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 22011–2014
- Markets registered in
- 897 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Advanced Brain Monitoring, 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 | Advanced Brain Monitoring, Inc. | 2 clearances | 2011–2014 | Below |
| Canada | Health Canada | Registration holder | ADVANCED BRAIN MONITORING, INC. | 62 | 2007–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Advanced Brain Monitoring Inc | 13 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | Advanced Brain Monitoring, Inc. | 12 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Advanced Brain Monitoring Inc | 4 | 2010–2021 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Advanced Brain Monitoring, Inc. | 4 | 2020–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Advanced Brain Monitoring, Inc | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Advanced Brain Monitoring, Inc. | 1 | 2014–2014 | 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 Advanced Brain Monitoring, 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 |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Apnea Guard | 2012 |
| Cervical (for Mild Sleep Apnea) PillowMYB · Class 2 | — | Maker | Night Shift Therapy | 2014 |
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 |
|---|---|---|
| ADVANCED BRAIN MONITORING, INC.FDA reg. 3004964738 | CARLSBAD, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9064303). 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.