Compass Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Compass Intl., Inc. makes
Compass Intl., Inc. manufactures the Regulus Navigator, a medical device designed for precise intraoperative navigation, and the Regulus Measurement Unit, which provides real-time imaging or measurement support during surgical procedures.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Regulus Navigator Ref K964229
Regimes: 510(k) Registry: 510(k)Regulus Measurement Unit Ref K935456
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Compass Intl., Inc. have in the registry?
The registry currently lists 2 devices for Compass Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Compass Intl., Inc.'s devices?
Among its 2 most recently registered devices, Compass Intl., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Compass Intl., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Compass Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Compass Intl., Inc. in the registry?
The most recently registered devices listed for Compass Intl., Inc. include REGULUS NAVIGATOR and REGULUS MEASUREMENT UNIT.