Bainbridge Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Bainbridge Laboratories, Inc. makes
Bainbridge Laboratories, Inc. manufactures the G-MARK, a diagnostic device used for detecting gastric emptying in patients, and the PYLORITRAK, a tool for evaluating pyloric function and motility in the gastrointestinal tract.
The company’s portfolio includes Class I and Class II devices, with products authorised via the FDA’s 510(k) pathway. These devices are listed under U.S. regulatory requirements, and the manufacturer is based in the United States.
Catalogue
G-Mark Ref K880076
Regimes: 510(k) Registry: 510(k)Pyloritrak Ref K912215
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bainbridge Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Bainbridge Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bainbridge Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Bainbridge Laboratories, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bainbridge Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bainbridge Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bainbridge Laboratories, Inc. in the registry?
The most recently registered devices listed for Bainbridge Laboratories, Inc. include G-MARK and PYLORITRAK.