Integra Biotechnical, LLC
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Integra Biotechnical, LLC makes
Integra Biotechnical, LLC manufactures I.V. extension sets and I.V. administration sets.
These Class II medical devices are listed in the FDA 510(k) registry, and the company is based in the United States.
Catalogue
I.V. Extension Set Or I.V. Administration Set Ref K983073
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Integra Biotechnical, LLC, initiated on 2007-02-01. By recorded status: 1 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.
2007
- 1 Feb 2007 Z-0714-2007 Unclassified (pre-2012) Terminated During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.
Frequently asked questions
How many devices does Integra Biotechnical, LLC have in the registry?
The registry currently lists 1 device for Integra Biotechnical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Integra Biotechnical, LLC's devices?
Among its 1 most recently registered device, Integra Biotechnical, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Integra Biotechnical, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Integra Biotechnical, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Integra Biotechnical, LLC?
FDA recall records list 1 recall initiated by Integra Biotechnical, LLC, the most recent initiated on 1 Feb 2007. 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 Integra Biotechnical, LLC in the registry?
The most recently registered devices listed for Integra Biotechnical, LLC include I.V. EXTENSION SET OR I.V. ADMINISTRATION SET.