Manufacturer registered with FDA
Ameda Instruments Company
Karachi, Pakistan. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 216 registrations outside the US
- Establishments
- 1Pakistan
Registered in 2 markets
Where regulators' registries name Ameda Instruments Company 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 | Ameda Instruments Company | 8 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Ameda Instruments Company | 16 | — | 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 Ameda Instruments Company currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mouth Mirrors | 2008 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Ligature DirectorsTwirl on | 2008 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | Bracket GaugeMirror Handles | 2008 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | — | 2008 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | — | 2008 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Adam PliersBracket Remover PliersSpecial Stop Pliers | 2008 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | Crown ScissorsMayo Scissors | 2008 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Bracket Removing AngledStep Pliers | 2008 |
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 |
|---|---|---|
| AMEDA INSTRUMENTS COMPANYFDA reg. 3003582728 | Karachi Sindh, Pakistan | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10025718). 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.