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Electrosurgical, Cutting & Coagulation & Accessories
FDA product code GEI · Class 2 · General, Plastic Surgery
50,862
Registered devices
117,696
Adverse events
644
Recalls
2,312
510(k) clearances
Devices with this code
DENSITY Tip — Jeisys Medical Inc.Pilling — Avalign Technologies, Inc.STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C.STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C.Symmetry Olsen — ASPEN SURGICAL PRODUCTS, INC.ProcedureKitCRF — CAMBRIDGE INTERVENTIONAL LLCSpeedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Symmetry Debakey — ASPEN SURGICAL PRODUCTS, INC.Adler Instrument Company — Adler, Inc.neXus — MISONIX, INC.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NA — Hangzhou AGS MedTech Co., Ltd.Integra® MicroFrance® — INTEGRA MICROFRANCESurgical Direct — Surgical Direct, Inc.PILLING — TELEFLEX INCORPORATEDSTINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C.STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C.Surgical Direct — Surgical Direct, Inc.Surgical Direct — Surgical Direct, Inc.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-18 | Olympus Corporation of the Americas | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. |
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2026-06-02 | Maquet Cardiovascular, LLC | Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization r |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-03-23 | Olympus Corporation of the Americas | Potential for detachment of a distal tip component of the device during use. |
| 2026-02-25 | Olympus Corporation of the Americas | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul |
| 2026-02-25 | Olympus Corporation of the Americas | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul |
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