Manufacturer registered with FDA
Speedway Surgical Co.
India, India. 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
- 413 registrations outside the US
- Establishments
- 1India
Registered in 4 markets
Where regulators' registries name Speedway Surgical Co. 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 | Speedway Surgical Co. | 1 device types | — | Below |
| India | CDSCO | Registration holder | SPEEDWAY SURGICAL CO | 10 | 2024–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SPEEDWAY SURGICAL CO | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Speedway surgical Co. | 1 | 2020–2020 | 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 Speedway Surgical Co. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | handle, instrument | 2023 |
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 |
|---|---|---|
| SPEEDWAYFDA reg. 3006550126 | India Delhi, India | Manufacturer |
Other names on FDA records
Speedway
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028319). 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.