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DXN

1,219 FDA 510(k) clearances · Product code

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RecordFirmDate
iHealth BP3L Wireless Blood Pressure Monitor (K152003)Andon Health Co, Ltd.2015-09-24
iHealth View BP7S Wireless Blood Pressure Wrist Monitor (K152379)Andon Health Co, Ltd.2015-09-23
Fully Automatic Electronic Blood Pressure Monitor (K151460)Andon Health Co, Ltd.2015-09-08
Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K151869)Microlife Intellectual Property GmbH, Switzerland2015-09-02
Full Automatic (NIBP)Blood Pressure Monitor (K150311)Health & Life Co., Ltd.2015-08-18
Digital Automatic Wrist Blood Pressure Monitor MD3200 (K151587)Grandway Technology (Shenzhen) Limited2015-08-07
Digital Automatic Wrist Blood Pressure Monitor MD3900 (K151583)Grandway Technology (Shenzhen) Limited2015-08-07
Digital Automatic Blood Pressure Monitor MD2300 (K143735)Grandway Technology (Shenzhen) Limited2015-07-23
Microlife Wrist Watch Blood Pressure Monitor (K151330)Microlife Intellectual Property GmbH, Switzerland2015-07-14
AUTOMATIC BLOOD PRESSURE MONITOR (K140762)Jawon Medical Co., Ltd.2015-07-02
AGE Automatic Wrist Blood Pressure Monitor (K151281)Dongguan Ageless Health Industrial Co., Ltd.2015-06-30
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] (K150373)Grandway Technology (Shenzhen) Limited2015-06-11
Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 (K143734)Grandway Technology (Shenzhen) Limited2015-05-02
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K141984)Andon Health Co, Ltd.2015-04-29
Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K143341)Microlife Intellectual Property GmbH2015-04-21
Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor (K150430)Fudakang Industrial Co., Ltd.2015-04-17
HEALTH KIOSK (K140360)Engagementhealth, LLC2015-04-10
ELECTRONIC BLOOD PRESSURE MONITOR (K141683)Shenzhen Urion Technology Co., Ltd.2015-04-03
Digital Automatic Wrist Blood Pressure Monitor MD2400 (K143733)Grandway Technology (Shenzhen) Limited2015-04-03
Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) (K150545)Sejoy Electronics & Instruments Co., Ltd.2015-04-02
HealthGuard-15 (K143108)Futrex, Inc.2015-03-27
FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR (K141460)Finapres Medical Systems B.V.2015-03-20
Full Automatic (NIBP) Blood Pressure Monitor (K142968)Health & Life Co., Ltd.2014-12-19
BP652N (HEM-6300-Z) (K142917)Omron Healthcare, Inc.2014-12-01
AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM (K133989)Mortara Instrument, Inc.2014-11-25
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K141755)Sejoy Electronics & Instruments Co., Ltd.2014-11-19
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES (K142088)Grandway Technology (Shenzhen) Limited2014-10-31
BLOOD PRESSURE MONITOR (K141416)Shenzhen Pump Medical System Co., Ltd.2014-10-09
A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR (K141201)A & D Co., Ltd.2014-10-08
A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR (K141160)A & D Co., Ltd.2014-10-07
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE (K141113)Spacelabs Healthcare, Ltd.2014-09-26
ABPM7100 (K140928)I.E.M. GmbH2014-09-15
HD BLOOD PRESSURE MONITOR (K141924)Biocare Asia Corporation , Ltd.2014-09-08
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR (K141083)Microlife Intellectual Property GmbH2014-08-22
BELTER BLOOD PRESSURE METER (K134029)Shenzhen Belter Health Measurement and Analysis TE2014-07-25
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K140572)Microlife Intellectual Property GmbH, Switzerland2014-07-02
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K140121)Andon Health Co, Ltd.2014-07-02
A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR (K141179)A & D Co., Ltd.2014-06-27
QARDIOARM (K140067)Qardio, Inc.2014-06-18
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES (K140583)Grandway Technology (Shenzhen) Limited2014-06-18
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM (K140312)Edwards Lifesciences, LLC2014-06-13
ANS1 SOFTWARE (K140412)Ld Technology, LLC2014-05-22
FORA CARE BLOOD PRESSURE MONITORING SYSTEM (K133588)Foracare, Inc.2014-04-25
WITHINGS BLOOD PRESURE MONITOR (K133125)Withings2014-03-24
BPROSOFT CASP PC SOFTWARE (K131916)Healthstats International Pte. , Ltd.2014-03-11
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES (K133619)Grandway Technology (Shenzhen) Limited2014-03-05
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES (K133618)Grandway Technology (Shenzhen) Limited2014-03-05
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE (K131788)Healthstats International Pte. , Ltd.2014-03-04
HEM-7320 (K133383)Omron Healthcare, Inc.2014-03-04
OREGON SCINTIFIC (K131245)Idt Technology Limited2014-01-17
HEM-7311 (K133379)Omron Healthcare, Inc.2014-01-16
ARM AUTOMATIC BLOOD PRESSURE MONITOR (K130325)Shenzhen Pump Medical System Co., Ltd.2013-12-24
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES (K132240)Grandway Technology (Shenzhen) Limited2013-12-16
BOSCH BLOOD PRESSURE METER (BP5000 BT) (K131026)Robert Bosch Healthcare Systems, Inc.2013-11-14
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K132627)Honsun (Nantong) Co., Ltd.2013-10-23
HEM-6221 (K131749)Omron Healthcare, Inc.2013-10-07
ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM (K130232)Jinxinbao Electronic Co.,Ltd2013-09-17
ANSWATCH WRIST MONITOR MODEL TS-0411 (K123130)Taiwan Scientific Corporation2013-09-17
AUTOMATIC BLOOD PRESSURE MONITOR (K130925)Honsun (Nantong) Co., Ltd.2013-09-12
BIOSPACE (K131064)Biospace Corporation Limited2013-09-04
PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 (K131558)Shenzhen Pango Electronic Co., Ltd.2013-08-30
AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR (K123882)Ageless Health Industrial2013-08-14
HEM-6131 (K131742)Omron Healthcare, Inc.2013-07-24
IHEALTH CLOUD (K131203)Andon Health Co, Ltd.2013-07-19
WRIST AUTOMATIC BLOOD PRESSURE MONITOR (K131463)Honsun (Nantong) Co., Ltd.2013-07-08
TRANSTEK BLOOD PRESSURE MONITOR (K131395)Guangdong Transtek Medical Electronics Co., Ltd.2013-06-19
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K130564)Health & Life Co., Ltd.2013-06-19
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K130563)Health & Life Co., Ltd.2013-06-18
PG-800A SERIES (K131569)Shenzhen Pango Electronic Co., Ltd.2013-06-14
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K131346)Microlife Intellectual Property GmbH2013-06-06
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K131121)Health & Life Co., Ltd.2013-05-29
WRIST AUTOMATIC BLOOD PRESSURE MONITOR (K123800)Little Doctor Electronic (Nantong)Co.,Ltd2013-05-15
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) (K122013)Microlife Corp.2013-05-13
DIGITAL BLOOD PRESSURE MONITOR (K123600)Little Doctor Electronic (Nantong)Co.,Ltd2013-05-03
NEXFIN MODEL 2 (K122381)Edwards Lifesciences, LLC2013-04-22
STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK (K123539)Stayhealthy, Inc.2013-04-22
PERSONAL HEALTH CENTER (PHC) (K122076)Adflow Health Networks, Inc.2013-04-15
BP652N (HEM-6300-Z) (K123498)Omron Healthcare, Inc.2013-03-21
APPS-HEALTH01 (K122098)Andon Health Co, Ltd.2013-03-21
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0 (K123073)Grandway Technology (Shenzhen) Limited2013-03-11
TRANSTEK BLOOD PRESSURE MONITOR (K123780)Zhongshan Transtek Electronics Co., Ltd.2013-03-01
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES (K120675)Grandway Technology (Shenzhen) Limited2013-02-14
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES (K120673)Grandway Technology (Shenzhen) Limited2013-02-14
COMPACT DIGITAL BLOOD PRESSURE MONITOR (K122810)Thermor , Ltd.2013-02-08
WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200 (K123839)Ningbo Diaier Electronic Co., Ltd.2013-01-11
TRANSTEK WRIST BLOOD PRESSURE MONITOR (K123669)Zhongshan Transtek Electronics Co., Ltd.2012-12-21
CARDIOSCOPE (K121266)Pulsecor Limited2012-12-11
TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM (K123446)United States Gtm Medical Devices, Inc.2012-12-07
BLIP MODEL BP-700WF (K123020)Carematix, Inc.2012-11-28
UFIT TEN-10 (K122443)Biosign Technologies, Inc.2012-11-20
SPHYGMOCOR XCEL (K122129)Atcor Medical2012-11-16
TANGO M2 BLOOD PRESSURE MONITOR (K122401)Suntech Medical, Inc.2012-11-02
HX-461 (K120545)Seers Technology Co., Ltd.2012-10-23
TRANSTEK WRIST BLOOD PRESSURE MONITOR (K122482)Zhongshan Transtek Electronics Co., Ltd.2012-10-22
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K121372)Andon Health Co, Ltd.2012-09-10
HEM-7200-Z (BP742) (K121932)Omron Healthcare, Inc.2012-08-29
YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION (K121025)Ya Horng Electronic Co., Ltd.2012-08-17
CONNECTED CARE CLINICAL APPLICATION (K120320)Watermark Medical, Inc.2012-08-14
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K120554)Sejoy Electronics & Instruments Co., Ltd.2012-08-10
DISITAL BLOOD PRESSURE MONITOR (K112620)Nihon Seimitsu Sokki Co., Ltd.2012-08-02
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