Cadwell Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 46
What Cadwell Laboratories, Inc. makes
Cadwell Laboratories, Inc. manufactures medical devices for neurodiagnostic applications, including disposable and reusable electrodes (such as cutaneous and nasal pressure modules), conductive gels (e.g., TEN-20 paste gel, Omni Prep Gel), and stimulatory electrodes like the Promontory Stimulating Electrode. Their portfolio also includes neurodiagnostic systems, such as the Cadwell 5200 and 6200A, designed for EEG and evoked potential testing.
The company’s devices are classified under FDA’s Class I and Class II categories, with relevant products listed via the 510(k) pathway. These products are intended for use in the US, where regulatory compliance aligns with FDA requirements for neurodiagnostic and electrophysiological equipment.
Catalogue
Search and filter all 46 devicesFrequently asked questions
How many devices does Cadwell Laboratories, Inc. have in the registry?
The registry currently lists 46 devices for Cadwell Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cadwell Laboratories, Inc.'s devices?
Among its 46 most recently registered devices, Cadwell Laboratories, Inc. has devices listed in FDA 510(k) (46 devices).
What risk classes do Cadwell Laboratories, Inc.'s devices fall under?
Among its 46 most recently registered devices, the classes recorded for Cadwell Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cadwell Laboratories, Inc. in the registry?
The most recently registered devices listed for Cadwell Laboratories, Inc. include PROMONTORY STIMULATING ELECTRODE, TEN-20 CONDUCTIVE PASTE GEL, GROUND PLATE ELECTRODE and KILOWIN.