Trudell Medical Intl.
CanadaFDA 510(k) applicant, unverified
- Devices
- 15
What Trudell Medical Intl. makes
Trudell Medical International manufactures breath-actuated nebulizers, including the AEROECLIPSE II and AEROECLIPSE DURABLE models, which deliver aerosolized medication via patient inhalation. The company also produces valved holding chambers such as the AEROCHAMBER MINI, AEROCHAMBER PLUS, and AEROCHAMBER MAX, designed to improve drug deposition in respiratory therapy. Additionally, it supplies aerosol delivery systems like the SOLARYS ventilator system and adapters such as the RESPICONNECT, which interface with respiratory devices. Compressors, including the OMBRA tabletop model, and portable nebulizer systems like the AEROPEP are also part of its portfolio.
All listed devices fall under FDA Class II regulation and have been authorised through the 510(k) clearance pathway. The company’s products are registered with the FDA’s 510(k) database, ensuring compliance with US medical device regulations. Trudell Medical International operates from the United States, adhering to domestic regulatory standards for respiratory and aerosol therapy devices.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Trudell Medical Intl. have in the registry?
The registry currently lists 15 devices for Trudell Medical Intl.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Trudell Medical Intl.'s devices?
Among its 15 most recently registered devices, Trudell Medical Intl. has devices listed in FDA 510(k) (15 devices).
What risk classes do Trudell Medical Intl.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Trudell Medical Intl.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Trudell Medical Intl. in the registry?
The most recently registered devices listed for Trudell Medical Intl. include AEROCHAMBER MINI VENTILATION CHAMBER, AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC), OMBRA TABLE TOP COMPRESSOR and AEROPEP.