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INSTITUT GEORGES LOPEZ

FDA Regulatory Profile

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