Registered with FDA
Buxton Biomedical Inc
East Hanover, NJ, 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
- 554 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Buxton 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 | Lister | Buxton Biomedical Inc | 1 device types | — | Below |
| Australia | TGA | Manufacturer | Buxton Biomedical Inc | 35 | 2004–2005 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Buxton BioMedical, incBuxton Biomedical · Buxton BioMedical, Inc. | 16 | 2021–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BUXTON BIOMEDICAL INC. | 2 | 2005–2010 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Buxton BioMedical, inc. | 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
Devices listed with FDA
What Buxton 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 |
|---|---|---|---|---|
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | VARIOUS TYPES OF RONGEUR | 1994 |
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 |
|---|---|---|
| BUXTON BIOMEDICAL, INC.FDA reg. 2248030 | EAST HANOVER, NJ, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9007901). 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.