INSTITUT GEORGES LOPEZ

FDA Regulatory Profile

INSTITUT GEORGES LOPEZ appears in FDA public data with 1 recall, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2220-2025, Class II) was initiated on March 13, 2025. Its most recent 510(k) clearance was granted on June 14, 2022.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2220-2025Class IIBrand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/CataloMarch 13, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K221386PERF-GEN Pulsatile Perfusion SolutionJune 14, 2022
K221387BEL-GEN Cold Storage SolutionJune 14, 2022
K211224RM4 Control UnitOctober 15, 2021