Medical Device Manufacturer · US , Vernon Hills , IL

Omron Healthcare, Inc. - FDA 510(k) Cleared Devices

68 submissions · 67 cleared · Since 1991
68
Total
67
Cleared
1
Denied
68 devices
26-50 of 68
Cleared Jan 27, 2012
MODEL HBP-1300
K113185 · DXN
Cardiovascular · 91d
Cleared Dec 08, 2011
MODEL PM3030
K110068 · NUH
Neurology · 332d
Cleared Sep 02, 2011
COMP A-I-R
K110860 · CAF
Anesthesiology · 157d
Cleared Mar 21, 2011
HEM-4030
K110501 · DXN
Cardiovascular · 27d
Cleared Sep 01, 2009
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
K091676 · FLL
General Hospital · 84d
Cleared Oct 22, 2008
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
K082812 · MWI
Cardiovascular · 28d
Cleared Oct 10, 2008
HEM-9000AI
K081654 · DXN
Cardiovascular · 120d
Cleared Feb 26, 2008
1500 PRO
K080289 · DXN
Cardiovascular · 22d
Cleared Jul 02, 2007
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
K071645 · MWI
Cardiovascular · 17d
Cleared May 09, 2007
COLIN PRESS MATE, MODEL BP S510
K063690 · MHX
Cardiovascular · 148d
Cleared Feb 23, 2007
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
K062263 · CAF
Anesthesiology · 203d
Cleared Nov 07, 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
K062043 · MNW
Gastroenterology & Urology · 111d
Cleared Aug 02, 2006
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
K061822 · DXN
Cardiovascular · 35d
Cleared Jun 09, 2006
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
K060766 · DPS
Cardiovascular · 79d
Cleared May 25, 2006
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
K060811 · CAF
Anesthesiology · 62d
Cleared Oct 28, 2005
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL...
K050233 · DXN
Cardiovascular · 269d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
K052153 · DXN
Cardiovascular · 30d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
K052154 · DXN
Cardiovascular · 30d
Cleared Jun 21, 2005
OMRON MODEL 514N TYMPANIC THERMOMETER
K051233 · FLL
General Hospital · 39d
Cleared Apr 05, 2005
OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
K042505 · DXN
Cardiovascular · 202d
Cleared Apr 05, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
K042506 · DXN
Cardiovascular · 202d
Cleared Jan 19, 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K043060 · MNW
Gastroenterology & Urology · 75d
Cleared Nov 10, 2004
OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906
K043018 · DXN
Cardiovascular · 8d
Cleared Feb 11, 2004
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL
K032305 · DXN
Cardiovascular · 201d
Cleared Dec 12, 2002
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773,...
K021682 · DXN
Cardiovascular · 204d
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