Aradigm Corp.
Country not established
- Devices
- 1
What Aradigm Corp. makes
Aradigm Corp. manufactures respiratory management devices, including the SMARTMIST system for asthma treatment and the SMARTMIST Spirometry Airway, designed for airway assessment and nebulization therapy. These products are intended for use in monitoring and delivering inhaled medications to patients with respiratory conditions.
The company’s portfolio is regulated under Class I medical devices in the United States, with devices authorised through the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, reflecting their compliance with applicable regulatory requirements.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aradigm Corp. have in the registry?
The registry currently lists 1 device for Aradigm Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aradigm Corp.'s devices?
Among its 1 most recently registered device, Aradigm Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Aradigm Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Aradigm Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Aradigm Corp. in the registry?
The most recently registered devices listed for Aradigm Corp. include SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100.