Manufacturer registered with FDA
Accompany Surgical
SIALKOT, Pakistan. Lists 47 dental device types with FDA across 1 registered establishment.
- Device types listed
- 47
- Brands and models
- 55
- 510(k) clearances
- 0as applicant
- Markets registered in
- 216 registrations outside the US
- Establishments
- 1Pakistan
Registered in 2 markets
Where regulators' registries name Accompany Surgical 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 | Accompany Surgical | 47 device types | — | Below |
| Brazil | ANVISA | Manufacturer | ACCOMPANY SURGICAL(PVT)LTD. | 16 | 2013–2015 | 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 Accompany Surgical currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Accompany Surgical lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Hu-Friedy Mfg Co., LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 6 Nov 2012 | K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | Hu-Friedy Mfg Co., LLC | EJI Cartridge Syringe |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ACCOMPANY SURGICALFDA reg. 8041151 | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8041151). 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.