MRPClass II

Analyzer, Nitric Oxide

Anesthesiology · 21 CFR 868.2380

MDR events35All time

Recalls0All time

Registered firms22Currently listed

510(k) clearances1All time

Recent MDR events

35 adverse event reports on file

NOXBOX INHALED NITRIC OXIDE DELIVERY SYSTEMJul 11, 2024
InjuryPraxair/linde Gas & Equipment Inc.MW5157242
INOMAX DSIRFeb 1, 2024
MalfunctionMallinckrodt Manufacturing Llc18621709
INOMAX DSIR (DELIVERY SYSTEM)Jul 16, 2014
MalfunctionIkaria3004531588-2014-00032
INOMAX DSIR (DELIVERY SYSTEM)Jul 16, 2014
MalfunctionIkaria3004531588-2014-00031
INOMAX DSIR (DELIVERY SYSTEM)Jul 2, 2014
InjuryIkaria3004531588-2014-00025
INOMAX DSIR (DELIVERY SYSTEM)Jun 13, 2014
MalfunctionIkaria3004531588-2014-00024
INOMAX DSIR (DELIVERY SYSTEM)May 15, 2014
MalfunctionIkaria3004531588-2014-00020
INOMAX DSIR (DELIVERY SYSTEM)May 13, 2014
MalfunctionIkaria3004531588-2014-00018
INOMAX DSIR (DELIVERY SYSTEM)Apr 3, 2014
MalfunctionIkaria3004531588-2014-00010
INOMAX DSIR (DELIVERY SYSTEM)Apr 1, 2014
MalfunctionIkaria3004531588-2014-00008

Event type breakdown

Malfunction24

Injury7

Unspecified3

Other1

Most-reported manufacturers

Ikaria18 Ino Therapeutics Llc/ikaria7 Ino Therapeutics, Llc/ikaria5 Ikaria.1 Karia1 Mallinckrodt Manufacturing Llc1 Praxair/linde Gas & Equipment Inc.1 Pulmonox Medical Corp.1

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

22 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Pulmonox Medical, Inc.Aug 14, 2003
K023014 · VIANOX DELIVERY SYSTEM, MODEL I