FDA.reportPublic FDA data

ICECURE MEDICAL LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087979593008797959ICECURE MEDICAL LTD.1N2026-01-017 HaEshel street, POB 3163 Caesarea Northern IL 3079504

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1261611984403992K240892XSense Cryoablation System with CryoprobesGEH2024-06-28
1261611555613649K183213IceSense 3, ProSense, MultiSenseGEH2019-12-20
1261611053670914K102360ICESENCE 3GEH2010-11-29
1261611925846990DEN220077ProSense™ SystemQXW2025-10-03
1261611293168315
1261611692620598

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEH32024-06-28
QXW12025-10-03

PMN#