Icecure Medical Ltd

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2650-2023Class IIIceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical pSeptember 16, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K260377XSense Cryoablation System with CryoProbesFebruary 24, 2026
DEN220077ProSense™ SystemOctober 3, 2025
K240892XSense Cryoablation System with CryoprobesJune 28, 2024
K183213IceSense 3, ProSense, MultiSenseDecember 20, 2019
K102360ICESENCE 3November 29, 2010