Biologic Therapies, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Biologic Therapies, Inc. makes
Biologic Therapies, Inc. manufactures intraosseous cannula systems, including the Bio-MAC and Bio-CORE, designed for vascular access in emergency and critical care settings.
These devices are classified as Class II 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
2015
- 23 Jan 2015 Z-1372-2015 Class II Terminated Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
- 23 Jan 2015 Z-1373-2015 Class II Terminated Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
- 23 Jan 2015 Z-1374-2015 Class II Terminated Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Frequently asked questions
How many devices does Biologic Therapies, Inc. have in the registry?
The registry currently lists 1 device for Biologic Therapies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biologic Therapies, Inc.'s devices?
Among its 1 most recently registered device, Biologic Therapies, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Biologic Therapies, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biologic Therapies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Biologic Therapies, Inc.?
FDA recall records list 3 recalls initiated by Biologic Therapies, Inc., the most recent initiated on 23 Jan 2015. 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 Biologic Therapies, Inc. in the registry?
The most recently registered devices listed for Biologic Therapies, Inc. include Intraosseous Cannula System Bio-MAC¿ and Bio-CORE.