BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ICECURE MEDICAL LTD.

    Reg #: 3008797959 · FEI: 3008797959 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ICECURE MEDICAL LTD.
    Registration Number
    3008797959
    FEI Number
    3008797959
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7 HaEshel street, POB 3163
    City
    Caesarea Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K183213

    Owner / Operator

    Firm Name
    IceCure Medical Ltd.
    Operator Number
    10035292
    Address
    7 HaEshel street, POB 3163
    City
    Caesarea
    State
    Northern
    Postal Code
    3079504
    Country
    IL
    Correspondent
    Maayan Levi

    US Agent

    Business Name
    Boston MedTech Advisors
    Contact Name
    Zvi Ladin
    Address
    990 Washington St Ste 204
    City
    Dedham
    State
    MA
    ZIP
    02026
    Country
    US
    Email
    [email protected]
    Phone
    781 4070900 ext. 104

    Products

    Device Name Product Code
    Guide, Needle, Surgical GDF
    Instrument, Manual, Surgical, General Use MDM
    Unit, Cryosurgical, Accessories GEH
    Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer QXW

    Proprietary Names

    ProSense Cryoablation System XSense Cryoablation System with CryoProbes

    Establishment Types

    Manufacture Medical Device