Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list IceCure Medical Ltd. with 4 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Feb 24, 2026: XSense Cryoablation System with CryoProbes.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 24, 2026 | XSense Cryoablation System with CryoProbesK260377 · GEH | 510(k) clearances |
| Jun 28, 2024 | XSense Cryoablation System with CryoprobesK240892 · GEH | 510(k) clearances |
| Dec 20, 2019 | IceSense 3, ProSense, MultiSenseK183213 · GEH | 510(k) clearances |
| Sep 16, 2019 | IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme Class II · Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryo | Device recalls |
| Nov 29, 2010 | ICESENCE 3K102360 · GEH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
