Data / Medical devices / Switzerland / LEM Surgical AG
LEM Surgical AG: FDA-registered device maker in Bern, Switzerland, 2 510(k) clearances
LEM Surgical AG is registered with the FDA (registration 3040312029) in Bern, Switzerland. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3040312029
- Address
- Morgenstrasse 136, Bern, Switzerland, 3018
- Owner or operator
- LEM Surgical AG (10093626)
- Roles
- Manufacturer
- First device listed
- June 13, 2025
- Registered through
- 2027
- Brand names listed
- Dynamis Robotic Surgical System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | 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 |
|---|---|---|---|---|---|---|
| June 20, 2026 | K260369 | Dynamis Robotic Surgical System | OLO | Substantially Equivalent | LEM Surgical AG | accessdata.fda.gov |
| April 23, 2025 | K243326 | Dynamis Robotic Surgical System | OLO | Substantially Equivalent | LEM Surgical AG | accessdata.fda.gov |
Compare with other makers
Updated June 20, 2026. 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.