Home › Device types › GXH
Device, Surgical, Cryogenic
FDA product code GXH · Class 2 · Neurology
37
Registered devices
52
Adverse events
2
Recalls
23
510(k) clearances
Devices with this code
Epimed — EPIMED INTERNATIONAL, INCAtriCure cryoICE cryoSPHERE MAX Cryoablation System — ATRICURE, INC.AtriCure cryoICE cryoSPHERE MAX Cryoablation System — ATRICURE, INC.Epimed — EPIMED INTERNATIONAL, INCEpimed — EPIMED INTERNATIONAL, INCcryoICE Cryoablation System — ATRICURE, INC.AtriCure cryoICE cryoSPHERE Cryoablation System — ATRICURE, INC.Epimed — EPIMED INTERNATIONAL, INCAtriCure cryoICE cryoXT — ATRICURE, INC.AtriCure cryoICE cryoSPHERE Cryoablation System — ATRICURE, INC.Epimed — EPIMED INTERNATIONAL, INCEpimed — EPIMED INTERNATIONAL, INCEpimed — EPIMED INTERNATIONAL, INCiovera Smart Tip — Pacira Pharmaceuticals, Inc.AtriCure cryoICE cryoXT — ATRICURE, INC.AtriCure cryoICE cryoSPHERE Cryoablation System — ATRICURE, INC.Epimed — EPIMED INTERNATIONAL, INCcryoICE Cryoablation System — ATRICURE, INC.iovera Smart Tip — Pacira Pharmaceuticals, Inc.iovera Smart Tip — Pacira Pharmaceuticals, Inc.AtriCure cryoICE Cryoablation System (CRYO2) — ATRICURE, INC.iovera — Pacira Pharmaceuticals, Inc.Epimed International, Inc. — EPIMED INTERNATIONAL, INCiovera — Pacira Pharmaceuticals, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-07-01 | Myoscience Inc | The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or |
| 2013-06-21 | Myoscience Inc | The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptor |
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