FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K212409 |
Airgas Therapeutics |
Ulspira TS Nitric Oxide Therapy System |
06/30/2023 |
K000186 |
DATEX-OHMEDA |
DATEX-OHMEDA INOVENT DELIVERY SYSTEM |
02/10/2000 |
K120216 |
GENO LLC |
GENOSYL MV-1000 |
05/16/2012 |
K061901 |
INO THERAPEUTICS |
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
12/14/2006 |
K093922 |
INO THERAPEUTICS |
INOMAX DS |
04/15/2010 |
K121021 |
INO THERAPEUTICS |
INOMAX DS (DELIVERY SYSTEM) |
09/24/2012 |
K080484 |
INO THERAPEUTICS |
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
08/06/2008 |
K110344 |
INO THERAPEUTICS |
INOMAX DSIR (DELIVERY SYSTEM) |
06/24/2011 |
K130605 |
INO THERAPEUTICS |
INOMAX DSIR (DELIVERY SYSTEM) |
05/02/2013 |
K071516 |
INO THERAPEUTICS LLC |
INOMAX DS |
10/03/2007 |
K081691 |
INO THERAPEUTICS LLC |
INOMAX DS (DELIVERY SYSTEM) |
08/28/2008 |
K092545 |
INO THERAPEUTICS LLC |
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
03/10/2010 |
K070867 |
INO THERAPEUTICS LLC |
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
04/27/2007 |
K113272 |
INO THERAPEUTICS LLC/DBA IKARIA |
INOMAX DS(DELIVERY SYSTEMS |
02/29/2012 |
K110635 |
INO THERAPEUTICS LLC/DBA IKARIA |
INOMAX DS(IR) (DELIVERY SYSTEM) |
06/23/2011 |
K131686 |
INO THERAPEUTICS/IKARIA |
INOMAX DSIR (DELIVERY SYSTEM) |
11/29/2013 |
K143213 |
INO Therapeutics/Ikaria |
INOmax DSIR Plus MRI |
07/10/2015 |
K193481 |
International Biomedical |
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System |
03/10/2020 |
K093260 |
INTERNATIONAL BIOMEDICAL, LTD. |
AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM |
12/16/2009 |
K220898 |
Linde Gas & Equipment Inc. |
NOxBOXi Nitric Oxide Delivery System |
04/27/2022 |
K231823 |
Linde Gas & Equipment Inc. |
NOxBOXi Nitric Oxide Delivery System |
08/11/2023 |
K211153 |
Mallinckrodt Manufacturing LLC |
Inomax DSIR |
04/20/2023 |
K200389 |
Mallinckrodt Manufacturing LLC |
INOmax DSIR Plus |
06/17/2020 |
DEN000001 |
OHMEDA MEDICAL |
OHMEDA INOVENT DELIVERY SYSTEM |
01/11/2000 |
K171696 |
Praxair Distribution, Inc |
NOxBOXi Nitric Oxide Delivery System |
10/02/2018 |
K201339 |
Praxair, Inc. |
The NOxBOXi Nitric Oxide Delivery System |
06/19/2020 |
K000653 |
PULMONOX MEDICAL CORP. |
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002 |
08/04/2000 |
K033779 |
PULMONOX MEDICAL, INC. |
VIANOX DELIVERY SYSTEM, MODEL II |
01/26/2004 |