LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system
[REGULATORY ACTION]Jun 23, 2026 · LEM Surgical · Dynamis Robotic Surgical System · Switzerland, Europe
Failure Mode
REGULATORY ACTION
Event Date
Jun 23, 2026
Primary Entity
LEM Surgical
Robotic Platform
Dynamis Robotic Surgical System
Jurisdiction / Location
Switzerland, Europe
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
LEM Surgical announced second FDA 510(k) clearance for next-generation humanoid robotic surgical system. Bern-based company.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://thespinemarketgroup.com/lem-surgical-announces-second-fda-510k-clearance-for-next-generation-humanoid-robotic-surgical-system/
https://thespinemarketgroup.com/lem-surgical-announces-second-fda-510k-clearance-for-next-generation-humanoid-robotic-surgical-system/
Related Incidents & Failure Precedents
6 records on file- NHTSA opens probe into 1.2 million Tesla Model 3 and Model Y vehicles over front suspension failures[REGULATORY ACTION]
Jul 31, 2026 · Tesla · Tesla Robotaxi (Model Y ADS) · Orlando, Florida, USA
Details - NHTSA grants Zoox temporary exemption to commercially deploy up to 2,500 robotaxis annually[REGULATORY ACTION]
Jul 30, 2026 · Zoox · Zoox Robotaxi · Miami
Details - Zoox clears final federal hurdle, receives NHTSA exemption to launch paid robotaxi service[REGULATORY ACTION]
Jul 30, 2026 · Zoox · Zoox Robotaxi · Miami
Details - NHTSA grants Zoox first-ever commercial FMVSS exemption for purpose-built robotaxi[REGULATORY ACTION]
Jul 30, 2026 · Zoox · Zoox Robotaxi · Miami
Details - NHTSA launches $5M SAE ITC partnership to develop first-ever AV performance standards and updates AV technical guidance[REGULATORY ACTION]
Jul 30, 2026 · Zoox · Zoox Robotaxi · Miami
Details - NHTSA grants Zoox temporary commercial deployment exemption for up to 2,500 robotaxis annually for two years[REGULATORY ACTION]
Jul 30, 2026 · Zoox · Zoox Robotaxi · Miami
Details
Incident Context & FAQ
What happened in LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system?
LEM Surgical announced second FDA 510(k) clearance for next-generation humanoid robotic surgical system. Bern-based company.
When did this incident occur?
The incident is recorded as occurring on June 23, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system?
Dynamis Robotic Surgical System by LEM Surgical is the recorded robot involved in this incident at Switzerland, Europe.
Has anyone responded to LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.