Alveolus, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Alveolus, Inc. makes
Alveolus, Inc. manufactures tracheobronchial and esophageal stent systems, including the Alveolus Alimaxx-E Esophageal Stent System, Aero Tracheobronchial Stent Technology System, Alveolus Aero DV Tracheobronchial Stent System, and Alveolus TB-STS Tracheobronchial Stent System. The company also produces the Alimaxx-B Uncovered Biliary Stent System and related variants such as the Aero Tracheobronchial Stent System, Model 90129-2XX, and the Aleolus/Enoventions Alimaxx-E DV Esophageal Stent System.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. Alveolus, Inc. is based in the United States.
Catalogue
Search and filter all 12 devicesFDA recalls
FDA recall records list 1 recall initiated by Alveolus, Inc., initiated on 2004-04-22. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 22 Apr 2004 Z-1487-04 Unclassified (pre-2012) Terminated The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to the very end of the stent.
Frequently asked questions
How many devices does Alveolus, Inc. have in the registry?
The registry currently lists 12 devices for Alveolus, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alveolus, Inc.'s devices?
Among its 12 most recently registered devices, Alveolus, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Alveolus, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Alveolus, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Alveolus, Inc.?
FDA recall records list 1 recall initiated by Alveolus, Inc., the most recent initiated on 22 Apr 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Alveolus, Inc. in the registry?
The most recently registered devices listed for Alveolus, Inc. include ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM, AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM, ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM and ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM.