Data / Medical devices / Stimulator, Photic, Evoked Response / United States
FDA-registered makers of Stimulator, Photic, Evoked Response in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Stimulator, Photic, Evoked Response (product code GWE). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Stimulator, Photic, Evoked Response
- Product code
- GWE
- Country
- United States
Makers of Stimulator, Photic, Evoked Response in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diagnosys LLC | Lowell, MA, United States | Manufacturer | 2 | November 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Anschel Technology Inc. | Rocky Point, NY, United States | Specification developer | 1 | June 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Cadwell Industries, Inc. | Kennewick, WA, United States | Manufacturer | 1 | June 11, 1998 | 0 | 0 | 0 | api.fda.gov |
| Diopsys Inc. | Middletown, PA, United States | Complaint file establishment, Specification developer | 1 | May 9, 2011 | 0 | 2 | 0 | api.fda.gov |
| Konan Medical Usa, Inc. | Irvine, CA, United States | Manufacturer | 1 | May 15, 2009 | 0 | 0 | 0 | api.fda.gov |
| LKC Technologies, Inc. | Germantown, MD, United States | Manufacturer | 1 | May 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Adm Tronics Unltd, Inc. | Northvale, NJ, 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 | |
| Intelligent Hearing Systems Corp. | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Neurology Incorporated | Middleton, WI, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden America Fulfillment Center | Foothill Ranch, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Soterix Medical,inc. | Woodbridge, NJ, United States | Manufacturer | 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.