Data / Medical devices / Switzerland / Swissmeda AG
Swissmeda AG: FDA-registered device maker in Baar Zug, Switzerland, 1 510(k) clearance
Swissmeda AG is registered with the FDA (registration 3009489134) in Baar Zug, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 25, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009489134
- Address
- Obermuehle 8, Baar Zug, Switzerland, 6340
- Owner or operator
- Swissmeda AG (10038687)
- Roles
- Manufacturer
- First device listed
- August 23, 2018
- Registered through
- 2026
- Brand names listed
- Swissmeda Dental Planning System, Swissmeda powered by Carestream Dental
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 25, 2012 | K112251 | SWISSMEDA DENTAL PLANNING SYSTEM | LLZ | Substantially Equivalent | Swissmeda AG | accessdata.fda.gov |
Compare with other makers
Updated January 25, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.