Data / Medical devices / Electrode, Electrosurgical
Electrode, Electrosurgical (JOS): 31 FDA-registered makers in 8 countries
31 establishments in 8 countries are registered with the FDA to make Electrode, Electrosurgical (product code JOS, Class 2, 21 CFR 878.4400). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on September 6, 2016, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JOS
- Device class
- 2
- Regulation
- 878.4400
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Germany | 8 |
| Mexico | 2 |
| Hong Kong | 2 |
| China | 2 |
| South Korea | 2 |
| Czechia | 1 |
| Taiwan | 1 |
Makers of Electrode, Electrosurgical
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Linvatec Corporation | Largo, FL, United States | Manufacturer | 2 | August 20, 1999 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Manufacturer | 1 | May 16, 1995 | 0 | 0 | 0 | api.fda.gov |
| Kirwan Surgical Products, LLC. | Marshfield, MA, United States | Manufacturer | 1 | September 15, 1989 | 0 | 0 | 0 | api.fda.gov |
| Megadyne Medical Products, Inc. | Cincinnati, OH, United States | Specification developer | 1 | October 2, 1990 | 0 | 0 | 0 | api.fda.gov |
| Olympus Winter & Ibe GMBH | Hamburg, Germany | Complaint file establishment, Exporter to the US, Specification developer | 1 | September 6, 2016 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Products Czech | Prerov II Predmosti, Czechia | Manufacturer | 1 | September 6, 2016 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | Plainfield, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | Boulder, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | Lafayette, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Custom Manufacturing Inc. | Elbert, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erbe Elektromedizin GMBH | TUEBINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ERBE Elektromedizin GmbH | Rangendingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LCCS Products Limited | Sai Ying Pun, Hong Kong | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing (qing Yuan) Ltd | QING YUAN Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing Ltd. | HENG LI, DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing, Ltd. | Kwai Chung, N.T., Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Deantronics Taiwan Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Deantronics, Ltd. | Sparks, NV, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RF Medical Co., Ltd | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Starmed Co.,ltd | Ilsandong-gu, Goyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Strub Medical GmbH & Co. KG | NEUHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 6, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.