The Surgical Company International B.V.

FDA Regulatory Profile

The Surgical Company International B.V. appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on November 18, 2025.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252636Fluido Compact SystemNovember 18, 2025
K211618Fluido Compact Blood and Fluid Warming SystemJune 5, 2023
K101705MISTRAL-AIR WARMING SYSTEMJuly 2, 2010