Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Cadwell Industries, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories9
Latest FDA decision2026-06-26
TypeNumberDevice NameCodeDateActions
510(k) K261442 Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayGXY2026-06-26 View
510(k) K250851 Hypnos (369054-200)OLZ2025-12-14 View
510(k) K242424 Bluebird Single-Use Respiratory Effort BeltMNR2024-12-18 View
510(k) K230415 Cadwell GuardianGWF2023-08-17 View
510(k) K201819 Cadwell Apollo SystemGWQ2020-09-29 View
510(k) K192624 ApneaTrakOLV2020-02-20 View
510(k) K190760 Cadwell Bolt SoftwareOLT2019-11-23 View
510(k) K181466 Cadwell Zenith SystemGWQ2018-09-01 View
510(k) K180269 Cadwell Apollo SystemGWQ2018-07-17 View
510(k) K162199 Cascade IOMAX Intraoperative MonitorGWF2017-03-02 View
510(k) K162383 Cadwell Sierra Summit, Cadwell Sierra AscentIKN2017-03-01 View
510(k) K161027 Cadwell AmpliScanOMA2016-11-08 View
↑