IceCure Medical , Ltd. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
IceCure Medical , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: XSense Cryoablation System with CryoProbes, XSense Cryoablation System with Cryoprobes, IceSense 3, ProSense, MultiSense
4
Total
4
Cleared
0
Denied
IceCure Medical , Ltd. has 4 FDA 510(k) cleared medical devices. Based in Caesarea, IL.
Latest FDA clearance: Feb 2026. Active since 2010. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by IceCure Medical , Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Boston Medtech Advisors, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - IceCure Medical , Ltd.
4 devices
Cleared
Feb 24, 2026
XSense Cryoablation System with CryoProbes
General & Plastic Surgery
19d
Cleared
Jun 28, 2024
XSense Cryoablation System with Cryoprobes
General & Plastic Surgery
88d
Cleared
Dec 20, 2019
IceSense 3, ProSense, MultiSense
General & Plastic Surgery
396d
Cleared
Nov 29, 2010
ICESENCE 3
General & Plastic Surgery
102d