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Electrosurgical, Cutting & Coagulation & Accessories
FDA product code GEI · Class 2 · General, Plastic Surgery
51,276
Registered devices
119,015
Adverse events
644
Recalls
2,319
510(k) clearances
Devices with this code
ELMED — ELMED INCORPORATEDELMED — ELMED INCORPORATEDBIPOLAR YASARGIL BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Hunter Grasper Tip — ORANGE SURGICAL INSTRUMENTS, LLCSurgical Direct — Surgical Direct, Inc.Neuroblade System — Clearmind Biomedical Inc.COBLATION — Smith & Nephew, Inc.Kirwan — KIRWAN SURGICAL PRODUCTS LLCKirwan — KIRWAN SURGICAL PRODUCTS LLCSpeedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Big-Tip — RF Medical Co.,Ltd.Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.Integra® Ruggles®-Redmond™ — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONPlumePen — Conmed CorporationReNew — MICROLINE SURGICAL, INC.Monopolar Metzenbaum Scissor, Mini Blade Tip, Disposable — ORANGE SURGICAL INSTRUMENTS, LLCNA — Richard Wolf GmbHGuenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbHGuenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbHSurgical Direct — Surgical Direct, Inc.STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C.ELMED — ELMED INCORPORATED
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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