ICECURE MEDICAL LTD.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Instrument, Manual, Surgical, General UseProduct code MDM (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800
Recalls & enforcement
- Class IIOngoing2019-09-16Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
FDA inspections (1)
- OAI2023-03-22Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “ICECURE MEDICAL LTD. (FEI 3008797959) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008797959-icecure-medical-ltd/
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