Data / Medical devices / Nystagmograph
Nystagmograph (GWN): 14 FDA-registered makers in 8 countries
14 establishments in 8 countries are registered with the FDA to make Nystagmograph (product code GWN, Class 2, 21 CFR 882.1460). 11 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 60 510(k) clearances under this code, the latest on July 30, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GWN
- Device class
- 2
- Regulation
- 882.1460
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Denmark | 2 |
| China | 2 |
| Ireland | 2 |
| Italy | 1 |
| Argentina | 1 |
| Belgium | 1 |
| Poland | 1 |
Makers of Nystagmograph
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 |
|---|---|---|---|---|---|---|---|---|
| Interacoustics A/S | Middelfart Syddanmark, Denmark | Complaint file establishment, Manufacturer, Specification developer | 6 | August 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Spryson America Inc | Pittsburgh, PA, United States | Manufacturer | 5 | November 29, 2019 | 0 | 3 | 0 | api.fda.gov |
| Natus Medical Denmark ApS | TAASTRUP Hovedstaden, Denmark | Complaint file establishment, Manufacturer, Specification developer | 3 | February 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Inventis SRL | Padova, Italy | Manufacturer | 2 | January 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ecleris SRL | Villa Martelli Buenos Aires, Argentina | Manufacturer | 1 | April 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| Huizhou Maxway Technology Co., Ltd. | Huizhou Guangdong, China | Manufacturer | 1 | November 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Isen Tech.&trading Co., Ltd. | Beijing, China | Manufacturer | 1 | April 26, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medtrak VNG, Inc | Henderson, NV, United States | Manufacturer, Specification developer | 1 | March 23, 1994 | 0 | 0 | 0 | api.fda.gov |
| Neurosync, Inc. | Holliston, MA, United States | Manufacturer | 1 | January 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| S.A. Instrumentation Difra | Eupen Liege, Belgium | Manufacturer | 1 | September 18, 2007 | 0 | 0 | 0 | api.fda.gov |
| Vestibular First | Broomall, PA, United States | Specification developer | 1 | November 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| DGS Diagnostics Sp. z o.o | Kolbaskowo Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Manufacturing Limited | GORT, Co. Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Sensory Ireland Ltd | Gort Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 30, 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.