Medical Device Manufacturer · US , Kennewick , WA

Cadwell Industries, Inc.

12 submissions · 12 cleared · Since 2014
12
Total
12
Cleared
0
Denied

Cadwell Industries, Inc. — FDA 510(k) Submissions

Cadwell Industries, Inc. has submitted 12 FDA 510(k) premarket notifications since 2014, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Full-montage Standard Electroencephalograph, Stimulator, Electrical, Evoked Response, Amplitude-integrated Electroencephalograph, Electromyograph, Diagnostic, Non-normalizing Quantitative Electroencephalograph Software . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Hypnos (369054-200)
K250851 · OLZ Automatic Event Detection... · Neurology
Dec 2025 268d
Bluebird Single-Use Respiratory Effort Belt
K242424 · MNR Ventilatory Effort Recorder · Anesthesiology
Dec 2024 125d
Cadwell Guardian
K230415 · GWF Stimulator, Electrical,... · Neurology
Aug 2023 182d
Cadwell Apollo System
K201819 · GWQ Full-montage Standard... · Neurology
Sep 2020 90d
ApneaTrak
K192624 · OLV Standard Polysomnograph... · Neurology
Feb 2020 150d
Cadwell Bolt Software
K190760 · OLT Non-normalizing... · Neurology
Nov 2019 243d
Cadwell Zenith System
K181466 · GWQ Full-montage Standard... · Neurology
Sep 2018 89d
Cadwell Apollo System
K180269 · GWQ Full-montage Standard... · Neurology
Jul 2018 167d
Cascade IOMAX Intraoperative Monitor
K162199 · GWF Stimulator, Electrical,... · Neurology
Mar 2017 209d
Cadwell Sierra Summit, Cadwell Sierra Ascent
K162383 · IKN Electromyograph, Diagnostic · Neurology
Mar 2017 188d
Cadwell AmpliScan
K161027 · OMA Amplitude-integrated... · Neurology
Nov 2016 210d
CADWELL FLEX EEG/PSG
K133355 · GWQ Full-montage Standard... · Neurology
Jan 2014 90d
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