Data / Medical devices / Stimulator, Nerve, Battery-Powered
Stimulator, Nerve, Battery-Powered (BXN): 13 FDA-registered makers in 8 countries
13 establishments in 8 countries are registered with the FDA to make Stimulator, Nerve, Battery-Powered (product code BXN, Class 2, 21 CFR 868.2775). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 63 510(k) clearances under this code, the latest on October 16, 2022, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- BXN
- Device class
- 2
- Regulation
- 868.2775
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| Germany | 4 |
| United States | 2 |
| China | 2 |
| South Africa | 1 |
| New Zealand | 1 |
| Ireland | 1 |
| Japan | 1 |
| Denmark | 1 |
Makers of Stimulator, Nerve, Battery-Powered
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 |
|---|---|---|---|---|---|---|---|---|
| Xavant Technology (pty) Ltd | Pretoria Gauteng, South Africa | Manufacturer | 4 | October 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Melsungen AG | MELSUNGEN Hesse, Germany | Exporter to the US, Specification developer | 3 | March 22, 2007 | 0 | 0 | 0 | api.fda.gov |
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, New Zealand | Complaint file establishment, Manufacturer | 2 | November 28, 1988 | 0 | 0 | 0 | api.fda.gov |
| Stockert GMBH | FREIBURG Baden-Wurttemberg, Germany | Manufacturer | 2 | March 22, 2007 | 0 | 0 | 0 | api.fda.gov |
| Anesthesia Associates, Inc. | San Marcos, CA, United States | Contract manufacturer, Manufacturer, Specification developer | 1 | June 18, 1981 | 0 | 0 | 0 | api.fda.gov |
| Easymed Instruments Co., Ltd. | Daliang, Shunde, Foshan Guangdong, China | Manufacturer | 1 | May 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Natus Manufacturing Limited | GORT, Co. Galway(County), Ireland | Complaint file establishment, Specification developer | 1 | February 8, 2007 | 0 | 0 | 0 | api.fda.gov |
| Pajunk GMBH Medizintechnologie | GEISINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | January 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Bowa-Electronic GMBH | GOMARINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hakko Co., Ltd. | CHIKUMA-SHI Nagano, Japan | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Systems, Inc. | Milaca, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paul E. Danchell A/S | Jyderup Sjaelland, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Meccan Import and Export Corp. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 16, 2022. 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.