ClearanceBrief
Panels › Cardiovascular › Product code DXN · Class 2

System, Measurement, Blood-Pressure, Non-Invasive

Regulation 870.1130

30510(k)s in 12 months (1,226 all time)
0recalls in 12 months (36 all time)
33recalls that name a 510(k)
Get daily alerts for DXNSample briefCSV

Top companies in DXN

Company510(k)sRecalls
Andon Health Co, Ltd.680
Health & Life Co., Ltd.550
OMRON Healthcare, Inc.370
Microlife Intellectual Property GmbH330
A&D Engineering, Inc.250
Grandway Technology (Shenzhen) Limited210
Nihon Seimitsu Sokki Co., Ltd.180
Welch Allyn, Inc.123
Guangdong Transtek Medical Electronics Co., Ltd.140
JOYTECH Healthcare Co., Ltd.140
Decided510(k)Device and applicantCode
Mar 9, 2021K202891Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Feb 10, 2021K201332Meditech ABPM-06 (BP6)
Meditech , Ltd., HU
DXN
Jan 27, 2021K193387Arm Electronic Sphygmomanometer
Shenzhen Changkun Technology Co., Ltd., CN
DXN
Jan 27, 2021K193386Wrist Electronic Sphygmomanometer
Shenzhen Changkun Technology Co., Ltd., CN
DXN
Jan 26, 2021K202934Blood Pressure Monitor
Bioland Technology, Ltd., CN
DXN
Jan 22, 2021K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
Edwards Lifesciences, LLC
DXN
Jan 6, 2021K200560InBody
Inbody Co., Ltd., KR
DXN
Dec 30, 2020K202372Upper Arm Electronic Blood Pressure Monitor
Conmo Electronic Company Limited, CN
DXN
Dec 17, 2020K200346Wrist Type Blood Pressure Monitor
Avita Corporation, TW
DXN
Dec 6, 2020K202599Transtek Wrist Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Dec 4, 2020K200716Electronic Blood Pressure Monitor
Shenzhen Pango Electronic Co., Ltd., CN
DXN
Dec 4, 2020K200442InBody
Inbody Co., Ltd., KR
DXN
Oct 9, 2020K200434V20, V20a, AVSM3 SNF
Mediana Co., Ltd., KR
DXN
Sep 21, 2020K201467Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
Bioland Technology, Ltd., CN
DXN
Aug 20, 2020K200939Electronic Blood Pressure Monitor
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
DXN
Aug 3, 2020K200649Arm-Type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co. , Ltd., CN
DXN
Jul 23, 2020K200738Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN
Jul 16, 2020K193456Arm Blood Pressure Monitor
Ningbo Ranor Medical Science & Technology Co., Ltd., CN
DXN
Jul 12, 2020K193628AGE Automatic Wrist Blood Pressure Monitor
Dongguan E-Test Technology Co., Ltd., CN
DXN
Jul 12, 2020K193627Automatic Upper Arm Blood Pressure Monitor
Dongguan E-Test Technology Co., Ltd., CN
DXN
Jul 10, 2020K193624Automatic Upper Arm Blood Pressure Monitor
Dongguan E-Test Technology Co., Ltd., CN
DXN
Jun 25, 2020K200437Blood Pressure Monitor
Shenzhen Jamr Technology Co., Ltd., CN
DXN
Jun 25, 2020K193348Blood Pressure Monitor
Shenzhen Viatom Technology Co., Ltd., CN
DXN
Jun 18, 2020K200297Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN
Jun 12, 2020K200521Full Automatic(NIBP) Blood Pressure Monitor
Health & Life Co., Ltd., TW
DXN
May 29, 2020K190982Automatic Digital Blood Pressure Monitor
Xiamen Ants Bro Technology Co., Ltd., CN
DXN
May 15, 2020K200287BP-BT Kiosk
Ld Technology, LLC
DXN
May 15, 2020K191745Medtronic Commander Flex
Medtronic Care Management Services
DXN
Apr 21, 2020K192609Globalcare Blood Pressure Monitor
Globalcare Medical Technology Co., Ltd., CN
DXN
Feb 21, 2020K191894Upper Arm Blood Pressure Monitor
Shenzhen Zhengkang Technology Co., Ltd., CN
DXN
Jan 23, 2020K192092Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
Seca GmbH & Co. KG, DE
DXN
Dec 23, 2019K192023Arm Blood Pressure Monitor
Truly Instrument Limited, CN
DXN
Nov 27, 2019K191673Upper Arm Blood Pressure Monitor
Famidoc Technology Company Limited, CN
DXN
Sep 16, 2019K190507Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co., Ltd., TW
DXN
Sep 11, 2019K183521CNAP Monitor
Cnsystems Medizintechnik GmbH, AT
DXN
Aug 30, 2019K192058EV1000 Clinical Platform NI, EV1000 Clinical Platform
Edwards Lifesciences, LLC
DXN
Aug 23, 2019K191180Electronic Blood Pressure Monitor
Shenzhen AOJ Medical Technology Co., Ltd., CN
DXN
Aug 19, 2019K190207Blood Pressure Monitor
Shenzhen Viatom Technology Co., Ltd., CN
DXN
Aug 7, 2019K190893Non-invasive Hemodynamic Blood Pressure Monitor
Vita-Course Technologies Co., Ltd., CN
DXN
Aug 2, 2019K181154Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
Shenzhen Med-Link Electronics Tech Co., Ltd., CN
DXN
Jul 29, 2019K190886Non-invasive blood pressure measurement systems
Joytech Healthcare Co. , Ltd., CN
DXN
Jul 22, 2019K191593Digital Automatic Blood Pressure Monitor MD36 Series
Grandway Technology (Shenzhen) Limited, CN
DXN
Jul 10, 2019K190818Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN
Jul 3, 2019K183058Arm-type Electronic Blood Pressure Monitor
Shenzhen Bsx Technology Electronics Co., Ltd., CN
DXN
Jun 24, 2019K190927Oscillometric Blood Pressure Monitor
Rudolf Riester GmbH, DE
DXN
Jun 21, 2019K190130The ClearSight finger cuffs
Edwards Lifesciences, LLC
DXN
Jun 13, 2019K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
Health & Life Co., Ltd., TW
DXN
Jun 4, 2019K183535Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
May 20, 2019K190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TB
Health & Life Co., Ltd., TW
DXN
May 16, 2019K183534Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.