ClearanceBrief
Panels › Anesthesiology › Product code MRN · Class 2

Apparatus, Nitric Oxide Delivery

Regulation 868.5165

0510(k)s in 12 months (33 all time)
2recalls in 12 months (18 all time)
15recalls that name a 510(k)
Get daily alerts for MRNSample briefCSV

Top companies in MRN

Company510(k)sRecalls
Ino Therapeutics102
Ino Therapeutics, LLC/Dba Ikaria25
NOXBOX LTD06
Mallinckrodt Manufacturing, LLC40
Linde Gas & Equipment, Inc.30
Vero Biotech, LLC03
Airgas Therapeutics20
Ino Therapeutics/Ikaria20
International Biomedical20
Pulmonox Medical Corp.20
Decided510(k)Device and applicantCode
Jan 17, 2025K242374ULSPIRA TS™ Nitric Oxide Therapy System
Airgas Therapeutics, LLC
MRN
Jan 3, 2025K242578EVOLVE Nitric Oxide Delivery System
Mallinckrodt Manufacturing, LLC
MRN
May 28, 2024K240410EVOLVE Nitric Oxide Delivery System
Malinckrodt Manufacturing, LLC
MRN
May 23, 2024K233251NOxBOXi Nitric Oxide Delivery System
Linde Gas & Equipment, Inc.
MRN
Dec 6, 2023K222930Evolve Nitric Oxide Delivery System
Mallinckrodt Manufacturing, LLC
MRN
Aug 11, 2023K231823NOxBOXi Nitric Oxide Delivery System
Linde Gas & Equipment, Inc.
MRN
Jun 30, 2023K212409Ulspira TS Nitric Oxide Therapy System
Airgas Therapeutics
MRN
Apr 20, 2023K211153Inomax DSIR
Mallinckrodt Manufacturing, LLC
MRN
Apr 27, 2022K220898NOxBOXi Nitric Oxide Delivery System
Linde Gas & Equipment, Inc.
MRN
Jun 19, 2020K201339The NOxBOXi Nitric Oxide Delivery System
Praxair, Inc.
MRN
Jun 17, 2020K200389INOmax DSIR Plus
Mallinckrodt Manufacturing, LLC
MRN
Mar 10, 2020K193481AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
International Biomedical
MRN
Oct 2, 2018K171696NOxBOXi Nitric Oxide Delivery System
Praxair Distribution, Inc.
MRN
Jul 10, 2015K143213INOmax DSIR Plus MRI
Ino Therapeutics/Ikaria
MRN
Nov 29, 2013K131686INOMAX DSIR (DELIVERY SYSTEM)
Ino Therapeutics/Ikaria
MRN
May 2, 2013K130605INOMAX DSIR (DELIVERY SYSTEM)
Ino Therapeutics
MRN
Sep 24, 2012K121021INOMAX DS (DELIVERY SYSTEM)
Ino Therapeutics
MRN
May 16, 2012K120216GENOSYL MV-1000
Geno, LLC
MRN
Feb 29, 2012K113272INOMAX DS(DELIVERY SYSTEMS
Ino Therapeutics, LLC/Dba Ikaria
MRN
Jun 24, 2011K110344INOMAX DSIR (DELIVERY SYSTEM)
Ino Therapeutics
MRN
Jun 23, 2011K110635INOMAX DS(IR) (DELIVERY SYSTEM)
Ino Therapeutics, LLC/Dba Ikaria
MRN
Apr 15, 2010K093922INOMAX DS
Ino Therapeutics
MRN
Mar 10, 2010K092545INOMAX DS (DELIVERY SYSTEM), MODEL 10003
Ino Therapeutics, LLC
MRN
Dec 16, 2009K093260AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
International Biomedical, Ltd.
MRN
Aug 28, 2008K081691INOMAX DS (DELIVERY SYSTEM)
Ino Therapeutics, LLC
MRN
Aug 6, 2008K080484INOMAX DS (DELIVERY SYSTEM), MODEL 10003
Ino Therapeutics
MRN
Oct 3, 2007K071516INOMAX DS
Ino Therapeutics, LLC
MRN
Apr 27, 2007K070867INOMAX DS (DELIVERY SYSTEM), MODEL 10003
Ino Therapeutics, LLC
MRN
Dec 14, 2006K061901INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
Ino Therapeutics
MRN
Jan 26, 2004K033779VIANOX DELIVERY SYSTEM, MODEL II
Pulmonox Medical, Inc., CA
MRN
Aug 4, 2000K000653AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
Pulmonox Medical Corp., CA
MRN
Feb 10, 2000K000186DATEX-OHMEDA INOVENT DELIVERY SYSTEM
Datex-Ohmeda
MRN
Jan 11, 2000DEN000001OHMEDA INOVENT DELIVERY SYSTEM
Ohmeda Medical
MRN

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.