Manufacturer registered with FDA
Scanlan International
Saint Paul, MN, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 155,379 registrations outside the US
- Establishments
- 1United States
Registered in 15 markets
Where regulators' registries name Scanlan International 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 | Scanlan International | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Scanlan International Inc. | 3,063 | — | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | SCANLAN INTERNATIONAL, INC.SCANLAN INTERNATIONAL,INC. | 1,779 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Scanlan International, Inc. | 291 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SCANLAN INTERNATIONAL, INC. | 61 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SCANLAN INTERNATIONAL | 55 | 1999–2012 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Scanlan International Inc.SCANLAN INTERNATIONAL, INC · SCANLAN INTERNATIONAL,INC · +2 | 35 | 1999–2023 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Scanlan International, Inc. | 23 | 2024–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Scanlan International | 20 | 2010–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Scanlan International, Inc. | 19 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SCANLAN INTERNATIONAL, INCORPORATED | 16 | 2025–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SCANLAN INTERNATIONALSCANLAN INTERNATIONAL INC. · SCANLAN INTERNATIONAL INC | 11 | 1986–2012 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SCANLAN INTERNATIONAL, INC. | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Scanlan International Inc. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SCANLAN INTERNATIONAL, INC. | 1 | 2024–2024 | 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 Scanlan International 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 HemostatEMD · Class 1 | Dental hand instruments | Maker | SCANLAN® Adson ForcepsSCANLAN® Bailey ForcepsSCANLAN® Bengolea ForcepsSCANLAN® Crafoord Artery ForcepsSCANLAN® DeBakey Cooley ForcepsSCANLAN® Delicate Mosquito ForcepsSCANLAN® Hartman Mosquito ForcepsSCANLAN® HemostatSCANLAN® Ochsner ForcepsSCANLAN® Phlebectomy Haemostat 1 moreSCANLAN® Vascular Forceps | 1977 |
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 |
|---|---|---|
| SCANLAN INTERNATIONAL, INC.FDA reg. 2126670 | Saint Paul, MN, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2126670). 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.