Omron Healthcare, Inc. - FDA 510(k) Cleared Devices
68
Total
67
Cleared
1
Denied
68 devices
Cleared
Nov 07, 2001
BODY FAT ANALYZER, MODEL HBF-306
Gastroenterology & Urology
162d
Cleared
Jul 03, 2000
OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
Cardiovascular
14d
Cleared
Jun 30, 2000
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
Cardiovascular
29d
Cleared
Jun 30, 2000
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
Cardiovascular
29d
Cleared
Jun 13, 1997
HBF-1000 OMRON BODY COMPOSITION ANALYZER
Gastroenterology & Urology
280d
Cleared
Mar 04, 1994
OMRON MASSAGER MODEL HM-45
Physical Medicine
112d
Cleared
Mar 04, 1994
OMBRON TWIN-HEAD MASSAGER MODEL HM-101
Physical Medicine
112d
Cleared
Mar 04, 1994
OMRON MASSAGER MODEL HM-102
Physical Medicine
106d
Cleared
Jun 29, 1993
OMRON TYMPANIC THERMOMETER MC-500
General Hospital
406d
Cleared
May 13, 1993
OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.
Cardiovascular
86d
Cleared
Apr 14, 1993
OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142
Dental
121d
Cleared
Apr 14, 1993
OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005
Dental
121d
Cleared
Dec 24, 1992
OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601
Cardiovascular
308d
Cleared
Dec 23, 1992
OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706
Cardiovascular
425d
Cleared
Sep 15, 1992
NE-U07
Anesthesiology
90d
Cleared
Sep 15, 1992
NE-U04/NE U04F
Anesthesiology
84d
Cleared
May 06, 1992
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
Anesthesiology
194d
Cleared
Nov 06, 1991
AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR
Cardiovascular
90d