Praxair, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Praxair, Inc. makes
Praxair, Inc. manufactures medical air mixers for blending oxygen and air in controlled ratios, as well as the NOxBOXi Nitric Oxide Delivery System for precise administration of nitric oxide in clinical settings.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Praxair Medical Air Mixer Ref K051192
Regimes: 510(k) Registry: 510(k)The NOxBOXi Nitric Oxide Delivery System Ref K201339
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Praxair, Inc., initiated on 2012-11-16. 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.
2012
- 16 Nov 2012 Z-0525-2013 Class I Terminated Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.
Full distribution text
- 16 Nov 2012 Z-0525-2013 Class I Terminated Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.
Frequently asked questions
How many devices does Praxair, Inc. have in the registry?
The registry currently lists 2 devices for Praxair, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Praxair, Inc.'s devices?
Among its 2 most recently registered devices, Praxair, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Praxair, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Praxair, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Praxair, Inc.?
FDA recall records list 1 recall initiated by Praxair, Inc., the most recent initiated on 16 Nov 2012. 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 Praxair, Inc. in the registry?
The most recently registered devices listed for Praxair, Inc. include PRAXAIR MEDICAL AIR MIXER and The NOxBOXi Nitric Oxide Delivery System.