Banyan Medical, LLC
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Banyan Medical, LLC makes
Banyan Medical, LLC manufactures disposable secondary cannulas and trocars, which are reusable access devices used in surgical procedures to create pathways for instruments or fluids.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Banyan Medical, LLC, initiated on 2016-09-07. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 7 Sep 2016 Z-0074-2017 Class II Terminated Potential lack of assurance of sterility
- 7 Sep 2016 Z-0075-2017 Class II Terminated Potential lack of assurance of sterility
Frequently asked questions
How many devices does Banyan Medical, LLC have in the registry?
The registry currently lists 1 device for Banyan Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Banyan Medical, LLC's devices?
Among its 1 most recently registered device, Banyan Medical, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Banyan Medical, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Banyan Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Banyan Medical, LLC?
FDA recall records list 2 recalls initiated by Banyan Medical, LLC, the most recent initiated on 7 Sep 2016. 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 Banyan Medical, LLC in the registry?
The most recently registered devices listed for Banyan Medical, LLC include BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR.