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Unit, Cryosurgical, Accessories

FDA product code GEH · Class 2 · General, Plastic Surgery

791
Registered devices
3,228
Adverse events
106
Recalls
263
510(k) clearances

Devices with this code

Freezpen® — H & O Equipments SACryoClear — CRYOCONCEPTS, LPtruFreeze — US EndoscopyLeisegang Cryotip for LM-900 — Coopersurgical, Inc.Leisegang Cryotip for LM-900 — Coopersurgical, Inc.Leisegang Cryotip for LM-900 — Coopersurgical, Inc.Cryo Professional — Koninklijke Utermöhlen N.V.C2 CryoBalloon — PENTAX OF AMERICA, INC.CryoIQ Dermatology tip D1 — CryoIQ global ABICEfx Cryoablation System - Zero Cost — BOSTON SCIENTIFIC CORPORATIONWallach — Coopersurgical, Inc.Up&Up — TARGET CORPORATIONIceSphere® 1.5 90° Cryoablation Needle — GALIL MEDICAL LTDErbe — Erbe Elektromedizin GmbHFrigitronics — Coopersurgical, Inc.Visual-ICE™ MRI — BOSTON SCIENTIFIC CORPORATIONERBE — Erbe Elektromedizin GmbHHYGEA — Hygea Medical Technology Co., Ltd.V-Probe™ — Varian Medical Systems, Inc.Dr Scholls Freeze Away 7ct Blue — SCHOLL'S WELLNESS COMPANY LLCHYGEA — Hygea Medical Technology Co., Ltd.25x5x5mm Cervical Probes — BRYMILL CORPORATION2cm Flat Probes — BRYMILL CORPORATIONcryoICE BOX — ATRICURE, INC.

Recent recalls

DateFirmReason
2026-06-26Erbe USA IncA strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in C
2026-02-12Erbe USA IncProbes may rupture/burst during activation
2026-02-12Erbe USA IncProbes may rupture/burst during activation
2026-02-12Erbe USA IncProbes may rupture/burst during activation
2025-08-18Boston Scientific CorporationCertain desiccant tube subassemblies were built with end caps that were not correctly tightened.
2025-08-18Boston Scientific CorporationCertain desiccant tube subassemblies were built with end caps that were not correctly tightened.
2025-03-24Boston Scientific CorporationBoston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of
2025-03-24Boston Scientific CorporationBoston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of
2025-03-24Boston Scientific CorporationBoston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of
2025-03-24Boston Scientific CorporationBoston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.