Data / Medical devices / NSX
NSX (NSX): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make NSX (product code NSX). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 18 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NSX
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Germany | 2 |
| China | 1 |
| Japan | 1 |
Makers of NSX
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 |
|---|---|---|---|---|---|---|---|---|
| Covidien | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fukuda Denshi Co., Ltd. | Bunkyo-ku Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LivaNova Deutschland GmbH | MUNCHEN Bavaria, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seca | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volk Optical Inc. | Mentor, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.