Cadwell Industries, Inc.
Cadwell Industries, Inc. holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2026, with 3 FDA device recalls on record.
Top product codes for Cadwell Industries, Inc.
FDA recalls by Cadwell Industries, Inc.
- Z-0141-2027 — Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. The low current stimulator has one (1) constant current output pair with a current range of 0.01-20 mA. The TCS stimulator has nine (9) independent constant current/constant voltage outputs, with current range of 50-1500 mA and voltage range of 50-1000 V. Component: Is the cortical component of the IOMAX system
- Z-2349-2024 — Cascade IOMAX Cortical Module, REF: 190296-200
- Z-1882-2024 — Cascade IOMAX Cortical Module, REF: 190296-200
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cadwell Industries, Inc.
- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- K250851 — Hypnos (369054-200)
- K242424 — Bluebird Single-Use Respiratory Effort Belt
- K230415 — Cadwell Guardian
- K201819 — Cadwell Apollo System
- K192624 — ApneaTrak
- K190760 — Cadwell Bolt Software
- K181466 — Cadwell Zenith System
- K180269 — Cadwell Apollo System
- K162199 — Cascade IOMAX Intraoperative Monitor
- K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent
- K161027 — Cadwell AmpliScan
- K133355 — CADWELL FLEX EEG/PSG
Data sourced from openFDA. This site is unofficial and independent of the FDA.