Manufacturer registered with FDA
Gynamed Instruments
Sialkot, Pakistan. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 31
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1Pakistan
Registered in 3 markets
Where regulators' registries name Gynamed Instruments 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 | Gynamed Instruments | 1 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | GYNAMED INSTRUMENTS | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | GYNAMED Instruments | 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 Gynamed Instruments currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cloward Retractor Straight, Blade 13mmCloward Retractor Straight, Blade 18mmCloward Retractor Straight, Blade 20mmCloward Retractor Straight, Blade 23mmDavis double ended Retractor, 15cmDoyen Retractor Handle only,Doyen Single Hook Retractor HandleHill Ferguson Retractor 22x65mm, SmallHill Ferguson Retractor 30x76mm, MediumHill Ferguson Retractor 35x76mm, Large 21 moreHill Ferguson Retractor 35x95mm, XlargeHill Ferguson Retractor Handle 4-1/2", (OD: 12mm, ID: 11mm)Hirschmann Anoscope, Regular Pattern, OD 16x65mm, SmallHirschmann Anoscope, Regular Pattern, OD 19x65mm, MediumHirschmann Anoscope, Regular Pattern, OD 22x65mm, LargePARSONNER EPICARDIAL Retractor 50mm, 3x3 ProngesSAWYER Retractor, Satin Finish, LARGE, Blade 1-1/2" x 3-1/2" with Grip HandleShanghai Finochietto Retractor, Infant Swivel Blades 12x40mm, Arm 75mm, Spread 90mmShanghai Finochietto Retractor, Neonatal Swivel Blades 10x30mm, Arm 50mm, Spread 85mmShanghai Finochietto Retractor, Pediatric Swivel Blades 15x50mm, Arm 110mm, Spread 110mmShanghai Finochietto Retractor, Small Infant Swivel Blades 12x34mm, Arm 75mm, Spread 90mmSkin Self-Retaining Retractor 4-1/2", Spread 85mmSt. Mark's Perineal Retractor 10" Long Frame OnlySt. Mark's Perineal Retractor 2" BladeSt. Mark's Perineal Retractor 3" BladeSt. Mark's Perineal Retractor 4" BladeSt. Mark's Perineal Retractor 8" Long Frame OnlySt. Mark's Perineal Retractor 8" Long Frame, with 2" Blade Pair SetSt. Mark's Perineal Retractor 8" Long Frame, with 2", 3", 4" Blade Pair SetSt. Mark's Perineal Retractor 8" Long Frame, with 3" Blade Pair SetSt. Mark's Perineal Retractor 8" Long Frame, with 4" Blade Pair Set | 2020 |
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 |
|---|---|---|
| GYNAMED INSTRUMENTSFDA reg. 3005974802 | Sialkot Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062687). 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.