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Unit, Cryosurgical, Accessories

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

816
Registered devices
3,274
Adverse events
107
Recalls
264
510(k) clearances

Devices with this code

TargetCool-e — RecensMedical, Inc.CryoProbe™ — H & O Equipments SACVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHYGEA — Hygea Medical Technology Co., Ltd.Premier — PREMIER DENTAL PRODUCTS COMPANYWallach LL100 — Coopersurgical, Inc.ClariFix — ARRINEX, INC.Premier — PREMIER DENTAL PRODUCTS COMPANYERBE — Erbe Elektromedizin GmbHWalgreens Freeze Skin Tag Remover — WALGREEN CO.IceEDGE® 2.4 90° Cryoablation Needle — GALIL MEDICAL LTDCryoProbe™ — H & O Equipments SAMIRA Cryosurgical Probe, Straight Cataract — MIRA, INC.AtriCure cryoICE cryoFORM Cryoablation System (CRYOF) — ATRICURE, INC.Single-Point 1.5 Thermal Sensor™ MultiPack — GALIL MEDICAL LTDIcePearl® 2.1 CX Prostate Cryoablation Kit / Visual-ICE® System — BOSTON SCIENTIFIC CORPORATIONEZ CONNECT2™ Dual Cylinder Adapter, psi — GALIL MEDICAL INC.Frigitronics — Coopersurgical, Inc.truFreeze — Csa Medical, Inc.CryoProbe™ — H & O Equipments SAtruFreeze — Csa Medical, Inc.Controller, Full/Swipe — C2 THERAPEUTICS, INC.Cryoprobe D3.4 mm/10G, 127 mm, Trocar, Spheric. — ICECURE MEDICAL LTDCareOne — Ahold U.S.A., Inc.

Recent recalls

DateFirmReason
2026-08-24Limitless Cryo Spa LLCLack of 510(k) clearance.
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

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