Linde Gas North America, LLC
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Linde Gas North America, LLC makes
Linde Gas North America, LLC manufactures portable oxygen systems, including the LIV LINDE INTEGRATED VALVE-PORTABLE OXYGEN SYSTEM (Model M706), designed for delivering oxygen therapy to patients.
This device falls under Class I regulation in the US and is listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Linde Gas North America, LLC, initiated on 2013-03-08. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 8 Mar 2013 Z-1561-2013 Class II Terminated A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
Frequently asked questions
How many devices does Linde Gas North America, LLC have in the registry?
The registry currently lists 1 device for Linde Gas North America, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Linde Gas North America, LLC's devices?
Among its 1 most recently registered device, Linde Gas North America, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Linde Gas North America, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Linde Gas North America, LLC's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Linde Gas North America, LLC?
FDA recall records list 1 recall initiated by Linde Gas North America, LLC, the most recent initiated on 8 Mar 2013. 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 Linde Gas North America, LLC in the registry?
The most recently registered devices listed for Linde Gas North America, LLC include LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706.