Data / Medical devices / Stimulator, Nerve
Stimulator, Nerve (ETN): 108 FDA-registered makers in 17 countries
108 establishments in 17 countries are registered with the FDA to make Stimulator, Nerve (product code ETN, Class 2, 21 CFR 874.1820). 35 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 97 510(k) clearances under this code, the latest on February 27, 2026, and lists 17 recall events (2 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- ETN
- Device class
- 2
- Regulation
- 874.1820
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 76 |
| China | 6 |
| Germany | 3 |
| Switzerland | 3 |
| Canada | 3 |
| Malaysia | 3 |
| Turkey | 2 |
| Italy | 2 |
| France | 2 |
| United Kingdom | 1 |
| Netherlands | 1 |
| Dominican Republic | 1 |
| Costa Rica | 1 |
| Singapore | 1 |
| Poland | 1 |
| Mexico | 1 |
| Indonesia | 1 |
Makers of Stimulator, Nerve
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 |
|---|---|---|---|---|---|---|---|---|
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer, Specification developer | 18 | February 10, 2026 | 0 | 7 | 2 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 7 | April 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Manufacturer | 7 | April 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| Inomed Medizintechnik GMBH | EMMENDINGEN Baden-Wurttemberg, Germany | Manufacturer | 5 | June 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Neurovision Medical Products, Inc. | Ventura, CA, United States | Manufacturer | 5 | October 19, 2012 | 0 | 4 | 0 | api.fda.gov |
| Checkpoint Surgical Inc. | Brecksville, OH, United States | Specification developer | 4 | August 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Checkpoint Surgical Inc. | Independence, OH, United States | Specification developer | 4 | August 26, 2021 | 0 | 1 | 0 | api.fda.gov |
| The Magstim Company Ltd. | Carmarthenshire Wales, United Kingdom | Complaint file establishment, Manufacturer | 4 | December 14, 2005 | 0 | 1 | 0 | api.fda.gov |
| Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi | Istanbul, Turkey | Exporter to the US, Manufacturer | 3 | March 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Invotec International, Inc. | Jacksonville, FL, United States | Manufacturer, Repackager or relabeler | 2 | October 31, 2013 | 0 | 0 | 0 | api.fda.gov |
| Retropsoas Technologies, LLC | Frontenac, MO, United States | Complaint file establishment, Specification developer | 2 | July 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| Rhythmlink International, LLC | Columbia, SC, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | September 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 2 | February 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Technomed Europe | Kerkrade Limburg, Netherlands | Manufacturer | 2 | August 28, 2012 | 0 | 1 | 0 | api.fda.gov |
| Ad-Tech Medical Instrument Corp. | Oak Creek, WI, United States | Manufacturer | 1 | May 6, 2016 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer | 1 | March 15, 1991 | 0 | 0 | 0 | api.fda.gov |
| Biosys Biyomedikal Muhendislik Sanayi Ve Ticaret Anonim Sirketi | Cankaya Ankara, Turkey | Manufacturer | 1 | December 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cadwell Industries, Inc. | Kennewick, WA, United States | Manufacturer, Specification developer | 1 | February 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Canadian Hospital Specialties Ltd. | OAKVILLE Ontario, Canada | Manufacturer | 1 | July 7, 1983 | 0 | 0 | 0 | api.fda.gov |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer, Manufacturer | 1 | April 19, 1991 | 0 | 0 | 0 | api.fda.gov |
| Epineuron Technologies Inc. | Mississauga Ontario, Canada | Complaint file establishment, Manufacturer | 1 | February 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 1 | April 11, 2003 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 1 | April 11, 2003 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 1 | September 15, 2005 | 0 | 0 | 0 | api.fda.gov |
| Noreaster Medical LLC | Lincoln, RI, United States | Specification developer | 1 | April 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Northgate Technologies Inc. | Elgin, IL, United States | Complaint file establishment, Manufacturer | 1 | November 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Onyx Healthcare Usa, Inc. | Orange, CA, United States | Manufacturer | 1 | March 16, 2012 | 0 | 0 | 0 | api.fda.gov |
| R & D Batteries, Inc. | Burnsville, MN, United States | Manufacturer | 1 | November 19, 1993 | 0 | 0 | 0 | api.fda.gov |
| Spes Medica S.P.A | Genova Liguria, Italy | Exporter to the US, Manufacturer | 1 | August 24, 2010 | 0 | 1 | 0 | api.fda.gov |
| Spes Medica S.P.A | BATTIPAGLIA Salerno, Italy | Contract manufacturer, Exporter to the US, Manufacturer | 1 | November 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| Spinal Elements, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 1 | July 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | July 1, 2014 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | February 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer | 1 | April 11, 2003 | 0 | 0 | 0 | api.fda.gov |
| Xian Friendship Medical Electronics Co., Ltd. | Xi'an Shaanxi, China | Contract manufacturer, Manufacturer | 1 | April 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Alphatec Spine, Inc. | Carlsbad, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Olive Branch | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ardiem Medical, Inc. | Indiana, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ATL Technology CR Limitada | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beyonics International Pte. Ltd. | SINGAPORE North West, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Betts Precision | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bradshaw Medical Inc. | Kenosha, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ducommun LaBarge Technologies | Appleton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elmed, Inc. | Glendale Heights, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineering CPR Inc. | mississauga Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exxelia Micropen | Honeoye Falls, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Oakland, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fiberoptics Technology, Inc. | Pomfret, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fideltronik Poland SP. Z O.O. | Sucha Beskidzka Malopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forefront Medical Technology (jiangsu) Co.,ltd | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Friedrich Daniels GMBH | SOLINGEN North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Little Ferry, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauthier Biomedical, Inc. | Grafton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insert Molding Solutions, Inc. | Cumming, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intelligent Hearing Systems Corp. | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions - Indianapolis | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lacey Manufacturing Company LLC | Bridgeport, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LEAD-LOK, INC. d.b.a Nissha Medical Technologies | Sandpoint, ID, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lowell,inc. | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mackay Manufacturing, Inc. | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neuralytix LLC | Fruita, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Shun Ye Medical Company, Ltd. | Cixi Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Neurology Incorporated | Middleton, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pine Moon Electronics Co., Ltd. | SHENZHEN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prospect Life Sciences | Westminster, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulse Technologies, Inc. | Quakertown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacira Pharmaceuticals, INC | San Diego, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Dayton | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qualitel Corporation | Everett, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R & D Medical Products, Inc. | Lake Forest, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ranfac Corp. | Avon, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Weigao Orthopaedic Device Co.,ltd | weihai Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Launch Electrical Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spineguard, SA | Vincennes Paris, France | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Spine | CESTAS Nouvelle-Aquitaine, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartronics Watertown LLC | Watertown, SD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technomed Asia, PT. | Bandung Jawa Barat, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victoria Precision Inc. | Trevose, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 27, 2026. 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.