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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 6 of 7

Device	Model / Reference	Registries	Class	Status
Cascade IOMAX	199306-200	FDA UDI	Class II	Active
Cadwell Extension Lead Wire	302129-200	FDA UDI	Class II	Active
Cadwell	302526-200-0232	FDA UDI	Class II	Active
Cadwell Mini-Crocodile Clip Lead Wire	302226-200	FDA UDI	Class II	Active
Cadwell	302516-200-0280	FDA UDI	N/A	Active
Cadwell Disposable Surface Electrode	302852-000-060	FDA UDI	Class II	Unknown
Easy III	190231-200	FDA UDI	Class II	Active
Cadwell EEG Gold Cup Electrode	302058-200	FDA UDI	Class II	Active
Cadwell Shielded Crocodile Clip Cable	202203-200	FDA UDI	Class II	Active
Cadwell	302565-200-9080	FDA UDI	Class II	Active
Cadwell	302516-200-9480	FDA UDI	N/A	Active
Cadwell	302644-200	FDA UDI	Class II	Active
Cadwell Mini-Crocodile Clip Lead Wire	302127-200	FDA UDI	Class II	Active
EasyNet	190212-200	FDA UDI	Class II	Active
Cadwell Guardian	199335-000-008	FDA UDI	Class II	Active
Sierra NMUS1	198289-200	FDA UDI	Class II	Active
Cadwell	302513-200-0000	FDA UDI	Class II	Active
Cadwell	190315-000	FDA UDI	Class II	Active
Cadwell	302767-200	FDA UDI	Class II	Active
Cadwell Twisted Disposable Subdermal Needle Electrode	302820-000-080	FDA UDI	Class II	Unknown
Cadwell Patch Electrode with Snap Connector	302699-200	FDA UDI	Class II	Active
Cadwell Side-by-Side Bipolar Probe	302429-000	FDA UDI	Class II	Unknown
Cadwell Quick Connect Adapter	302228-200	FDA UDI	Class II	Active
Sierra Summit/Ascent	199277-200	FDA UDI	Class II	Active
Cadwell Probe Extension Kit	302151-200	FDA UDI	Class II	Active
Cadwell	302555-200-0080	FDA UDI	Class II	Active
Cascade Elite	190239-200	FDA UDI	Class II	Active
Cadwell Single Disc Electrode	302087-200	FDA UDI	Class II	Active
Cadwell Disposable Disc Electrode	302294-000-120	FDA UDI	Class II	Unknown
Cadwell	302531-200-0080	FDA UDI	N/A	Active
Cadwell Mini-Crocodile Clip Lead Wire	302253-200	FDA UDI	Class II	Unknown
Cascade Extender Pod	199252-200	FDA UDI	Class II	Active
Cadwell Disposable Surface Electrode	302853-000-100	FDA UDI	Class II	Unknown
Cadwell	302549-200-9080	FDA UDI	Class II	Active
Cadwell Disposable Hook Probes	302422-000	FDA UDI	Class II	Unknown
Cadwell EEG Gold Cup Electrode	302695-200	FDA UDI	Class II	Active
Sierra Wave	190217-200	EUDAMEDFDA UDI	Class II	Active
Cadwell Disposable Surface Electrode	302853-000-060	FDA UDI	Class II	Unknown
Apollo	190304-200	FDA UDI	Class II	Active
Easy Ambulatory	190206-200	FDA UDI	Class II	Unknown
Cadwell Replacement Stimulator Probe	339084-200	FDA UDI	Class II	Active
Cadwell Shielded Interconnect Cable	302176-200	FDA UDI	Class II	Active
Cadwell	302768-200	FDA UDI	Class II	Active
Cadwell Ring Electrode	302172-200	FDA UDI	Class II	Active
Cadwell Shielded Cable	302204-200	FDA UDI	Class II	Active
Cadwell Extension Lead Wire	302137-200	FDA UDI	Class II	Active
Cadwell Mini-Crocodile Clip Lead Wire	302227-200	FDA UDI	Class II	Active
Cascade	190262-200	FDA UDI	Class II	Active
Cadwell Patch Electrode with Snap Connector	302300-200-060	FDA UDI	Class II	Active
Cadwell	302563-200-1024	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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.