Omron Healthcare, Inc. - FDA 510(k) Cleared Devices
68
Total
67
Cleared
1
Denied
68 devices
Cleared
Jan 27, 2012
MODEL HBP-1300
Cardiovascular
91d
Cleared
Dec 08, 2011
MODEL PM3030
Neurology
332d
Cleared
Sep 02, 2011
COMP A-I-R
Anesthesiology
157d
Cleared
Mar 21, 2011
HEM-4030
Cardiovascular
27d
Cleared
Sep 01, 2009
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
General Hospital
84d
Cleared
Oct 22, 2008
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
Cardiovascular
28d
Cleared
Oct 10, 2008
HEM-9000AI
Cardiovascular
120d
Cleared
Feb 26, 2008
1500 PRO
Cardiovascular
22d
Cleared
Jul 02, 2007
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
Cardiovascular
17d
Cleared
May 09, 2007
COLIN PRESS MATE, MODEL BP S510
Cardiovascular
148d
Cleared
Feb 23, 2007
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
Anesthesiology
203d
Cleared
Nov 07, 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
Gastroenterology & Urology
111d
Cleared
Aug 02, 2006
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
Cardiovascular
35d
Cleared
Jun 09, 2006
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
Cardiovascular
79d
Cleared
May 25, 2006
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
Anesthesiology
62d
Cleared
Oct 28, 2005
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL...
Cardiovascular
269d
Cleared
Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
Cardiovascular
30d
Cleared
Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
Cardiovascular
30d
Cleared
Jun 21, 2005
OMRON MODEL 514N TYMPANIC THERMOMETER
General Hospital
39d
Cleared
Apr 05, 2005
OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
Cardiovascular
202d
Cleared
Apr 05, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
Cardiovascular
202d
Cleared
Jan 19, 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
Gastroenterology & Urology
75d
Cleared
Nov 10, 2004
OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906
Cardiovascular
8d
Cleared
Feb 11, 2004
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL
Cardiovascular
201d
Cleared
Dec 12, 2002
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773,...
Cardiovascular
204d