Manufacturer registered with FDA
Nova Biomedical
Waltham, MA, United States. Lists 1 dental device type with FDA across 2 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6147 registrations outside the US
- Establishments
- 2United States
Registered in 6 markets
Where regulators' registries name Nova Biomedical 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 | Nova Biomedical | 1 device types | — | Below |
| Brazil | ANVISA | Manufacturer | NOVA BIOMEDICAL CORPORATION | 75 | 2015–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NOVA BIOMEDICAL CORPORATIONNova Biomedical Corporation · NOVA BIOMEDICAL · +1 | 27 | 2006–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NOVA BIOMEDICAL CORPORATIONNOVA BIOMEDICAL · NOVA BIOMEDICAL CORP. | 20 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NOVA BIOMEDICAL CORPORATIONNOVA BIOMEDICAL · NOVA BIOMEDICAL CORP. | 15 | 2017–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Nova Biomedical CorporationNova Biomedical | 10 | — | 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 Nova Biomedical currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Nova Stat Profile pHOx Plus C | 2007 |
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 |
|---|---|---|
| Nova Biomedical CorporationFDA reg. 3023162659 | Billerica, MA, United States | Manufacturer, Remanufacturer |
| NOVA BIOMEDICAL CORPORATIONFDA reg. 1219029 | WALTHAM, MA, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1219029). 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.