Manufacturer registered with FDA
Planmed Oy
Helsinki, Finland. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 32015–2022
- Markets registered in
- 15116 registrations outside the US
- Establishments
- 1Finland
510(k) clearances per year, 2007–2026
Registered in 15 markets
Where regulators' registries name Planmed Oy 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 | Planmed Oy | 3 clearances | 2015–2022 | Below |
| Canada | Health Canada | Registration holder | PLANMED OY | 66 | 1999–2021 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Planmed OY | 7 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PLANMED OYPlanmed Oy | 7 | 2010–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Planmed Oy | 6 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | PLANMED OYPlanmed Oy · Planmed Oy. | 6 | 2000–2013 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Planmed Oy | 4 | 2024–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Planmed Oy | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Planmed Oy | 3 | 2009–2026 | Pure Global AI |
| China | NMPA | Registration holder | 普兰梅德公司Planmed Oy | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Planmed Oy | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PLANMED OY | 2 | 2014–2017 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PLANMED OY | 2 | 2012–2022 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Planmed Oy | 2 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Planmed Oy | 1 | 2013–2013 | 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 Planmed Oy 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 Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | Planmed Verity | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Planmed Oy as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Planmed OyFDA reg. 8043728 | Helsinki Uusimaa, Finland | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023610). 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.