Cadwell Industries, Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array510(k)Jun 26, 2026Neurology	Neurology	510(k)Substantially Equivalent (Abbreviated)	Jun 26, 2026
Hypnos (369054-200)510(k)Dec 14, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 14, 2025
Bluebird Single-Use Respiratory Effort Belt510(k)Dec 18, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 18, 2024
Cadwell Guardian510(k)Aug 17, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 17, 2023