b-ONE Ortho Corp.
United Statesfrom the FDA registration address FDA establishment FEI 3042508254
b-ONE Ortho Corp. is a medical device manufacturer, with 1,449 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 12 Nov 2026.
- Devices
- 1,449
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 1,436
- FDA 510(k) 13
- Device classes
- FDA Class II 1,125
- FDA Class I 324
- Identifiers
- FDA FEI 3042508254
Catalogue
Search and filter all 1,449 devicesShowing 1-50 of 1,449
Company details
- FDA FEI number
- 3042508254
- Address
- 159 Dwight Pl, Fairfield, NJ, 07004
Frequently asked questions
How many devices does b-ONE Ortho Corp. have in the registry?
The registry currently lists 1449 devices for b-ONE Ortho Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list b-ONE Ortho Corp.'s devices?
Among its 50 most recently registered devices, b-ONE Ortho Corp. has devices listed in FDA GUDID (50 devices).
What risk classes do b-ONE Ortho Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for b-ONE Ortho Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from b-ONE Ortho Corp. in the registry?
The most recently registered devices listed for b-ONE Ortho Corp. include MOBIO™ Total Knee System 8821333209, MOBIO™ Total Knee System 8821333210, MOBIO™ Total Knee System 8821333211 and MOBIO™ Total Knee System 8821333213.