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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)

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Device	Model / Reference	Registries	Class	Status
Cadwell Jumper Cable	302167-200	FDA UDI	Class II	Active
Arc Essentia	198232-200	FDA UDI	Class II	Active
Cadwell Clip-On Lead Wire	302773-200	FDA UDI	Class II	Active
EasyNet	190210-200	FDA UDI	Class II	Active
Cadwell Lead Wire	302781-200	FDA UDI	Class II	Active
Cadwell Single Disc Electrode	302136-200	FDA UDI	Class II	Active
Cadwell EEG Gold Cup Electrode	302768-200	FDA UDI	Class II	Active
Cadwell Feld Pads	302703-200	FDA UDI	Class II	Active
Cadwell Disposable Disc Electrodes	302291-000	FDA UDI	Class II	Unknown
Cadwell Disposable Ground Electrode	302850-000-080	FDA UDI	Class II	Unknown
Cadwell Single Disc Electrode	302135-200	FDA UDI	Class II	Active
Cascade Pro	190265-200	FDA UDI	Class II	Active
Cadwell Lead Wire	198259-200	FDA UDI	Class II	Unknown
Arc Essentia	190290-200	FDA UDI	Class II	Active
Sierra NMUS1	198288-200	FDA UDI	Class II	Active
Cadwell Subdermal Corkscrew	302358-000	FDA UDI	Class II	Unknown
Cadwell XL Monopolar Stimulating Probe	302416-000	FDA UDI	Class II	Unknown
Cadwell Bar Electrode	302089-200	FDA UDI	Class II	Active
Cadwell EEG Gold Cup Electrode	302055-200	EUDAMEDFDA UDI	Class II	Active
Cadwell EEG Gold Cup Electrode Pak	302691-200	FDA UDI	Class II	Active
Easy III	190229-200	FDA UDI	Class II	Active
Cadwell Ring Electrode	302788-200	FDA UDI	Class II	Active
Cadwell Lead Wire	198263-200	FDA UDI	Class II	Unknown
Cadwell Zenith System	K181466	FDA 510(k)	Class II	Active
Cadwell AmpliScan	K161027	FDA 510(k)	Class II	Active
Cascade IOMAX Intraoperative Monitor	K162199	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Cadwell Guardian	K230415	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Cadwell Sierra Summit, Cadwell Sierra Ascent	K162383	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Cadwell Apollo System	K180269	FDA 510(k)	Class II	Active
Bluebird Single-Use Respiratory Effort Belt	K242424	FDA 510(k)	Class II	Active
Cadwell Apollo System	K201819	FDA 510(k)	Class II	Active
Cadwell Flex Eeg/Psg	K133355	FDA 510(k)	Class II	Active
Hypnos (369054-200)	K250851	FDA 510(k)	Class II	Active
ApneaTrak	K192624	FDA 510(k)	Class II	Active
Cadwell Bolt Software	K190760	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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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.