MROClass IILife-sustaining
Apparatus, Nitric Oxide, Backup Delivery
Anesthesiology · 21 CFR 868.5165
MDR events5All time
Recalls0All time
Registered firms16Currently listed
510(k) clearances4All time
Recent MDR events
5 adverse event reports on file
- INOBLENDERNov 28, 2019InjuryMallinckrodt Manufacturing Llc3004531588-2019-00137
- INOBLENDER (BACKUP DELIVERY SYSTEM)Nov 19, 2013OtherIkaria3004531588-2013-00026
- INOBLENDER (BACKUP DELIVERY SYSTEM)Apr 15, 2013OtherIkaria3004531588-2013-00009
- INOBLENDERMar 27, 2012InjuryIno Therapeutics Llc/ikaria3004531588-2012-00002
- INO BLENDERMar 9, 2012MalfunctionIkaria2501105
Event type breakdown
Injury2
Other2
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
16 firms currently registered for this product code
510(k) clearances
4 clearances for this product code