Praxair Inc.

FDA Regulatory Profile

Praxair Inc. appears in FDA public data with 3 recalls — including 1 Class I (most serious) —, 2 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0782-2016, Class III) was initiated on September 16, 2015. Its most recent 510(k) clearance was granted on June 19, 2020.

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
2
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0782-2016Class IIIUN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MSeptember 16, 2015
D-0783-2016Class IIIUN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55September 16, 2015
Z-0525-2013Class IPraxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG UsagNovember 16, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K201339The NOxBOXi Nitric Oxide Delivery SystemJune 19, 2020
K051192PRAXAIR MEDICAL AIR MIXERSeptember 6, 2005