CMR SURGICAL LIMITED

FDA Regulatory Profile

CMR SURGICAL LIMITED appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2717-2026, Class II) was initiated on June 9, 2026. Its most recent 510(k) clearance was granted on December 16, 2025.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2717-2026Class IIBrand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog NumbeJune 9, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K252111Versius Surgical System (Versius Plus)December 16, 2025
DEN230078Versius Surgical SystemOctober 11, 2024