Manufacturer registered with FDA
Medos International SARL
Palm Beach Gardens, FL, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 163,672 registrations outside the US
- Establishments
- 1Switzerland
Registered in 16 markets
Where regulators' registries name Medos International SARL 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 | Medos International SARL | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | MEDOS INTERNATIONAL SARL | 1,456 | 1998–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Medos International SARL | 555 | 2021–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | MEDOS INTERNATIONAL SARL | 423 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Medos International SARLMEDOS INTERNATIONAL SARL | 340 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | Medos International SARL | 273 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Medos International SARL | 221 | 2009–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MEDOS INTERNATIONAL SARLMedos International Sarl | 78 | 2000–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Medos International SARLMedos International Sarl · MEDOS INTERNATIONAL SARL | 63 | 2011–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Medos International SARLMedos International Sarl · Medos International Sàrl | 62 | — | Pure Global AI |
| China | NMPA | Registration holder | 迈道国际有限公司Medos International SARL迈道国际有限公司 Medos International SARL | 53 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MEDOS INTERNATIONAL SARLMEDOS INTERNATIONAL S.A.R.L. | 50 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MEDOS INTERNATIONAL SARLMedos International SARL | 46 | 1999–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEDOS INTERNATIONAL SARL | 38 | 2013–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Medos International SARL | 7 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Medos International SARL | 7 | 2010–2012 | 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 Medos International SARL currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | SYMPHONY - GDS | 2016 |
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
Medos International SARL 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: Depuyacromed (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Jan 2001 | K003286 | SYMPHONY GRAFT DELIVERY SYSTEM | Depuyacromed | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDOS INTERNATIONAL SARLFDA reg. 3008114965 | Le Locle Neuchatel, Switzerland | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10031083). 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.