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Cadwell Industries, Inc.

United States·US-MF-000001265

Last updated September 17, 2026

About

Helping you help others. Cadwell helps patients, physicians, clinics, and hospitals around the world by delivering innovative neurodiagnostic and neuromonitoring solutions, improving clinical efficiency, and providing market leading customer support.

From the manufacturer's own website. Source

What Cadwell Industries, Inc. makes

Cadwell Industries, Inc. manufactures polysomnographs, home-use sleep apnoea recording systems, electromyographs, electroencephalographs, and neurophysiologic monitoring systems. The company also produces related components such as single-use electromyographic needle electrodes, analytical scalp electrodes, electrode conductive medium, and various lead wires and patch electrodes with snap connectors.

The devices are classified as Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. Cadwell Industries, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does Cadwell Industries, Inc. manufacture?

Where is Cadwell Industries, Inc. based?

Cadwell Industries, Inc. is based in the United States. This information is explicitly stated in the provided device data under the COMPANY and COUNTRY fields, confirming the company’s location without referencing any approval status or certifications.

In which regulatory registries are Cadwell Industries, Inc.'s devices listed?

Cadwell Industries, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries. This indicates that the devices have undergone premarket notification review and are assigned unique device identifiers for tracking, but it does not imply that the company itself is approved or cleared.

How are Cadwell Industries, Inc.'s devices classified under regulatory frameworks?

Cadwell Industries, Inc.'s devices are classified as Class II medical devices. This classification reflects a moderate level of risk and requires special controls to ensure safety and effectiveness, such as performance standards and post-market surveillance, but does not constitute an approval of the company as a whole.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 909, North Kellogg St, Kennewick, United States
Website: www.cadwell.com
LinkedIn: linkedin.com/company/cadwell-laboratories
Facebook: facebook.com/cadwelllabs
Email: [email protected]
Phone: +1 800 245 3001
PRRC Contact: Beata (Becky) Corral
EUDAMED SRN: US-MF-000001265
FDA FEI Number: 3020018
DUNS Number: —

Catalogue (335)

Page 3 of 7

Device	Model / Reference	Registries	Class	Status
Cadwell	302510-200-1480	FDA UDI	N/A	Active
Cadwell Disposable Double Ball-Tip Probe	302431-000	FDA UDI	Class II	Unknown
Cadwell Disposable Monopolar Probe	302427-000	FDA UDI	Class II	Unknown
Cadwell EEG Gold Cup Electrode	302641-200	FDA UDI	Class II	Active
Sierra Wave	199219-200	FDA UDI	Class II	Unknown
Cadwell	302555-200-1024	FDA UDI	Class II	Active
Cascade IOMAX	199291-200	FDA UDI	Class II	Active
Cadwell Ring Electrode	302143-200	FDA UDI	Class II	Active
Cascade IOMAX Intraoperative Monitor	190296-200	FDA UDI	Class II	Active
Cadwell Disposable Subdermal Needle Electrode	302353-000-080	FDA UDI	Class II	Unknown
Cascade	190194-200	FDA UDI	Class II	Active
Cadwell Disposable Hook Probes	302424-000	FDA UDI	Class II	Unknown
Cadwell Bar Electrode	302147-200	FDA UDI	Class II	Active
Cadwell	302539-200-1080	FDA UDI	Class II	Active
Cadwell	302523-200-0400	FDA UDI	Class II	Active
Zenith	199297-200	FDA UDI	Class II	Active
Cadwell Disposable Monopolar Probe	302427-000-275	FDA UDI	Class II	Unknown
Cadwell Crocodile Clip	302126-200	FDA UDI	Class II	Active
Cadwell Disposable Monopolar Probe	302400-000	FDA UDI	Class II	Unknown
Cadwell EEG Gold Cup Electrode Pak	302736-200	FDA UDI	Class II	Active
Cadwell Lead Wire	302774-200-180	FDA UDI	Class II	Active
Apollo	190302-200	FDA UDI	Class II	Active
Cadwell Ground Plate Electrode	302189-200	FDA UDI	Class II	Active
Cadwell Single Disc Electrode	302787-200	FDA UDI	Class II	Active
Sierra Wave	199224-200	FDA UDI	Class II	Active
Cadwell	302519-200-0000	FDA UDI	Class II	Active
Cadwell	302510-200-0280	FDA UDI	N/A	Active
Cadwell Twisted Disposable Subdermal Needle Electrode	302820-000-040	FDA UDI	Class II	Unknown
Cadwell	302571-200-0280	FDA UDI	N/A	Active
Cadwell Disposable Disc Electrode	302294-000-080	FDA UDI	Class II	Unknown
Cadwell Shielded Interconnect Cable	302192-200	FDA UDI	Class II	Active
Cadwell	302522-200-0080	FDA UDI	Class II	Active
Cadwell	302556-200-0080	FDA UDI	Class II	Active
Easy Ambulatory	190257-200	FDA UDI	Class II	Unknown
Cadwell	302550-200-0000	FDA UDI	Class II	Active
Cadwell	302519-200-9000	FDA UDI	Class II	Active
Cascade	190221-200	FDA UDI	Class II	Active
Cadwell	302567-200-9080	FDA UDI	Class II	Active
Arc Essentia	199283-000-025	FDA UDI	Class II	Active
Cadwell	302556-200-9080	FDA UDI	Class II	Active
Cadwell Bar Electrode	302085-200	FDA UDI	Class II	Active
Sierra Summit	190276-200	FDA UDI	Class II	Active
Sierra Summit/Ascent	190282-200	FDA UDI	Class II	Active
Cadwell Patch Electrode with Snap Connector	302696-000	FDA UDI	Class II	Unknown
Easy III	190249-200	FDA UDI	Class II	Active
Cadwell	302530-200-0080	FDA UDI	N/A	Active
Cadwell	302522-200-0020	FDA UDI	Class II	Active
Cadwell	302566-200-0080	FDA UDI	Class II	Active
Cadwell Disposable Hook Probes	302421-000	FDA UDI	Class II	Unknown
Cadwell Mini-Crocodile Clip Lead Wire	302124-200	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 2 recall records for Cadwell Industries, Inc., with the earliest initiated on 2024-04-23 and the most recent initiated on 2024-05-17. The statuses recorded are open and classified. The reasons given are: potential incorrect installation of an insulator in an electroneurodiagnostic medical device that could result in arcing to patient connections and potential unintended shock; and a defective printed circuit board in an electroneurodiagnostic medical device that may cause damage to internal components and result in unintended electrical stimulation.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 17, 2024	Z-2349-2024	—	open, classified	Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
Apr 23, 2024	Z-1882-2024	—	open, classified	There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.