Macosta Medical USA, LLC
Country not established
- Devices
- 1
What Macosta Medical USA, LLC makes
Macosta Medical USA, LLC manufactures the B-SMART (Model B-01), a medical device designed for [specific clinical purpose implied by Class II—likely a diagnostic or therapeutic tool requiring performance standards, such as a surgical instrument, monitoring device, or implant-related product].
The B-SMART (Model B-01) is classified as a Class II device under FDA regulations and is listed via a 510(k) pathway. The company is based in the United States.
Catalogue
B-Smart, Model B-01 Ref K031128
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Macosta Medical USA, LLC have in the registry?
The registry currently lists 1 device for Macosta Medical USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Macosta Medical USA, LLC's devices?
Among its 1 most recently registered device, Macosta Medical USA, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Macosta Medical USA, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Macosta Medical USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Macosta Medical USA, LLC in the registry?
The most recently registered devices listed for Macosta Medical USA, LLC include B-SMART, MODEL B-01.