FDA.reportPublic FDA data

ICECURE MEDICAL LTD.

Matched from indexed company URL: Icecure Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087979593008797959ICECURE MEDICAL LTD.1N2026-01-017 HaEshel street, POB 3163 Caesarea Northern IL 3079504
30091349063009134906ICECURE MEDICAL, INC.1Y2026-01-0139 Parker Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07290015487061Temperature Sensor - Temperature Sensor - Use only with IceCure Cryogenic device+16468443066icecuresupport@icecure-medical.com
07290015487160PROSENSE™ SYSTEM 100-127 VAC - FAS3000000+16468443066icecuresupport@icecure-medical.com
07290015487160PROSENSE™ SYSTEM 100-127 VAC - FAS300000018889025716icecuresupport@icecure-medical.com

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#

GUDID#