Data / Medical devices / Amplifier, Physiological Signal / United States
FDA-registered makers of Amplifier, Physiological Signal in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Amplifier, Physiological Signal (product code GWL). 7 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Amplifier, Physiological Signal
- Product code
- GWL
- Country
- United States
Makers of Amplifier, Physiological Signal in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Blackrock Microsystems | Salt Lake City, UT, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | February 10, 2021 | 0 | 2 | 0 | api.fda.gov |
| Intelligent Hearing Systems Corp. | Miami, FL, United States | Manufacturer | 2 | August 31, 2005 | 0 | 0 | 0 | api.fda.gov |
| Neurotronics, LLC | Alachua, FL, United States | Manufacturer | 2 | July 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Brainmatterz, Inc | McKinney, TX, United States | Manufacturer | 1 | June 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| CGX, LLC | San Diego, CA, United States | Specification developer | 1 | May 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Natus Neurology Incorporated | Middleton, WI, United States | Specification developer | 1 | April 8, 2011 | 0 | 1 | 0 | api.fda.gov |
| REMware | Tampa, FL, United States | Manufacturer | 1 | September 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cadwell Industries, Inc. | Kennewick, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi Tech Electronic Manufacturing Corporation | Oceanside, CA, United States | Contract 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.