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Omron Healthcare, Inc.

68 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) (DEN230076)Omron Healthcare, Inc.2024-10-08
Omron Model BP7900 Blood Pressure Monitor + EKG (K202228)Omron Healthcare, Inc.2021-04-01
Focus TENS Therapy, Model PM710-M/-L (K183215)Omron Healthcare, Inc.2019-09-07
HEM-6410T-ZL Wrist Blood Pressure Monitor (K190693)Omron Healthcare, Inc.2019-04-17
Omron Model BP7900 Blood Pressure Monitor + EKG (K182579)Omron Healthcare, Inc.2019-03-14
Maxpower Relief (K182120)Omron Healthcare, Inc.2019-01-10
Heat Pain Pro (K181992)Omron Healthcare, Inc.2018-11-09
HEM-6410T-ZM Wrist Blood Pressure Monitor (K182481)Omron Healthcare, Inc.2018-11-09
Wrist Blood Pressure Monitor Model BP4350 (K182166)Omron Healthcare, Inc.2018-11-08
Wrist Blood Pressure Monitor Model BP6100 (K182127)Omron Healthcare, Inc.2018-11-02
Avail (K172079)Omron Healthcare, Inc.2017-10-19
HEM-9210T (K163235)Omron Healthcare, Inc.2017-04-20
Omron HEM-6400T-Z Wrist Blood Pressure Monitor (K163045)Omron Healthcare, Inc.2017-02-21
Evolv Model BP7000 Upper Arm Blood Pressure Monitor (K162092)Omron Healthcare, Inc.2016-11-22
Heat Pain Pro (K160115)Omron Healthcare, Inc.2016-06-03
MAXPOWER RELIEF (K141978)Omron Healthcare, Inc.2014-12-03
BP652N (HEM-6300-Z) (K142917)Omron Healthcare, Inc.2014-12-01
COMP A-I-R (K141140)Omron Healthcare, Inc.2014-09-30
HEM-7320 (K133383)Omron Healthcare, Inc.2014-03-04
HEM-7311 (K133379)Omron Healthcare, Inc.2014-01-16
HEM-6221 (K131749)Omron Healthcare, Inc.2013-10-07
HEM-6131 (K131742)Omron Healthcare, Inc.2013-07-24
BP652N (HEM-6300-Z) (K123498)Omron Healthcare, Inc.2013-03-21
HEM-7200-Z (BP742) (K121932)Omron Healthcare, Inc.2012-08-29
LONG LIFE PADTM (K120516)Omron Healthcare, Inc.2012-05-17
MODEL HBP-1300 (K113185)Omron Healthcare, Inc.2012-01-27
MODEL PM3030 (K110068)Omron Healthcare, Inc.2011-12-08
COMP A-I-R (K110860)Omron Healthcare, Inc.2011-09-02
HEM-4030 (K110501)Omron Healthcare, Inc.2011-03-21
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 (K091676)Omron Healthcare, Inc.2009-09-01
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR (K082812)Omron Healthcare, Inc.2008-10-22
HEM-9000AI (K081654)Omron Healthcare, Inc.2008-10-10
1500 PRO (K080289)Omron Healthcare, Inc.2008-02-26
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S (K071645)Omron Healthcare, Inc.2007-07-02
COLIN PRESS MATE, MODEL BP S510 (K063690)Omron Healthcare, Inc.2007-05-09
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 (K062263)Omron Healthcare, Inc.2007-02-23
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 (K062043)Omron Healthcare, Inc.2006-11-07
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 (K061822)Omron Healthcare, Inc.2006-08-02
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 (K060766)Omron Healthcare, Inc.2006-06-09
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 (K060811)Omron Healthcare, Inc.2006-05-25
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI (K050233)Omron Healthcare, Inc.2005-10-28
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC (K052154)Omron Healthcare, Inc.2005-09-08
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL (K052153)Omron Healthcare, Inc.2005-09-08
OMRON MODEL 514N TYMPANIC THERMOMETER (K051233)Omron Healthcare, Inc.2005-06-21
OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N (K042505)Omron Healthcare, Inc.2005-04-05
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M (K042506)Omron Healthcare, Inc.2005-04-05
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 (K043060)Omron Healthcare, Inc.2005-01-19
OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 (K043018)Omron Healthcare, Inc.2004-11-10
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL (K032305)Omron Healthcare, Inc.2004-02-11
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC (K021682)Omron Healthcare, Inc.2002-12-12
BODY FAT ANALYZER, MODEL HBF-306 (K011652)Omron Healthcare, Inc.2001-11-07
OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (K001848)Omron Healthcare, Inc.2000-07-03
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 (K001671)Omron Healthcare, Inc.2000-06-30
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757 (K001670)Omron Healthcare, Inc.2000-06-30
HBF-1000 OMRON BODY COMPOSITION ANALYZER (K963575)Omron Healthcare, Inc.1997-06-13
OMBRON TWIN-HEAD MASSAGER MODEL HM-101 (K935462)Omron Healthcare, Inc.1994-03-04
OMRON MASSAGER MODEL HM-102 (K935581)Omron Healthcare, Inc.1994-03-04
OMRON MASSAGER MODEL HM-45 (K935459)Omron Healthcare, Inc.1994-03-04
OMRON TYMPANIC THERMOMETER MC-500 (K922344)Omron Healthcare, Inc.1993-06-29
OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT. (K930798)Omron Healthcare, Inc.1993-05-13
OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005 (K926247)Omron Healthcare, Inc.1993-04-14
OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142 (K926246)Omron Healthcare, Inc.1993-04-14
OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601 (K920778)Omron Healthcare, Inc.1992-12-24
OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706 (K914823)Omron Healthcare, Inc.1992-12-23
NE-U04/NE U04F (K923024)Omron Healthcare, Inc.1992-09-15
NE-U07 (K922923)Omron Healthcare, Inc.1992-09-15
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09 (K914836)Omron Healthcare, Inc.1992-05-06
AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR (K913523)Omron Healthcare, Inc.1991-11-06

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Every clearance here is in the API, with alerts when new ones post.