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
Jan 19, 2007K062027A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR
A&D Engineering, Inc.
DXN
Nov 8, 2006K061935SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR
Sensacare , Ltd., TW
DXN
Sep 29, 2006K062462NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L
Jawon Medical Co., Ltd., KR
DXN
Sep 15, 2006K061557FUSION
Medwave, Inc.
DXN
Sep 11, 2006K061471MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC
Microlife Intellectual Property GmbH
DXN
Aug 22, 2006K061959MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310
Mytech Technology Co., Ltd., TW
DXN
Aug 18, 2006K061279LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Little Doctor (Shanghai) Electronic
DXN
Aug 14, 2006K061760ARM BLOOD PRESSURE MONITOR, MODEL KP-7600
K-Jump Health Co., Ltd., TW
DXN
Aug 10, 2006K061086DM-3000 DIGITAL BLOOD PRESSURE MONITOR
Nihon Seimitsu Sokki Co., Ltd.
DXN
Aug 2, 2006K061822OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
Omron Healthcare, Inc.
DXN
Jul 12, 2006K061452TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM
Tung FU Electric Co., Ltd., TW
DXN
Jun 29, 2006K061558MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U
Microlife Intellectual Property GmbH
DXN
Jun 26, 2006K061161BLOOD PRESSURE METER, MODEL CH-311B
Citizen Watch Co., Ltd.
DXN
Jun 21, 2006K061456A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR
A&D Engineering, Inc.
DXN
Jun 14, 2006K061403MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U
Microlife Intellectual Property GmbH
DXN
Jun 9, 2006K060686MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC
Microlife Intellectual Property GmbH, CH
DXN
Jun 7, 2006K060820CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060
Suntech Medical, Inc.
DXN
Jun 2, 2006K061073CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250
Taidoc Technology Corporation, TW
DXN
May 9, 2006K060925ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112
ACON Laboratories, Inc.
DXN
May 5, 2006K053453HOMMED CENTRAL STATION, VERSION 3.5
Honeywell Hommed, LLC
DXN
Apr 21, 2006K060835HL888SF
Health & Life Co., Ltd., TW
DXN
Apr 12, 2006K060729FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV
Health & Life Co., Ltd., TW
DXN
Apr 7, 2006K060315HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
Healthstats International Pte. , Ltd.
DXN
Apr 4, 2006K060703PMP4 BP PRO BLOOD PRESSURE MONITOR
Card Guard Scientific Survival , Ltd., IL
DXN
Apr 4, 2006K060342ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
Rossmax International , Ltd., TW
DXN
Mar 14, 2006K060504IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001
Ideal Life, Inc.
DXN
Mar 8, 2006K060077RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A
Real Tone Technology Corp., CN
DXN
Feb 28, 2006K052450KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
Kodon(Tianjin)Electronic&Electrical Apparatus Co.,, CN
DXN
Feb 17, 2006K052676KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Kodon(Tianjin)Electronic&Electrical Apparatus Co.,, CN
DXN
Feb 13, 2006K060194MARCH HEALTHCARE HEALTH MONITORING KIT
March Healthcare Corporation, CA
DXN
Feb 3, 2006K052671HOCA EZ-CARE BP108, TENDER-CARE BP109
Hoca Medical Microsystem, Inc., TW
DXN
Jan 24, 2006K053185PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
Medwave, Inc.
DXN
Jan 5, 2006K053209TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM
Suntech Medical, Inc.
DXN
Jan 5, 2006K051847KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
Kodon(Tianjin)Electronic&Electrical Apparatus Co.,, CN
DXN
Dec 30, 2005K053304COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
Cardiocom, LLC
DXN
Dec 30, 2005K053303CARDIOCOM COMMANDER III
Cardiocom, LLC
DXN
Dec 27, 2005K051903FETALGARD LITE-NIBP, MODEL FGL-NIBP
Analogic Corporation
DXN
Dec 23, 2005K053395BP PRO BLOOD PRESSURE MONITOR
Card Guard Scientific Survival , Ltd., IL
DXN
Dec 16, 2005K052727ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350
Rossmax International , Ltd., TW
DXN
Nov 23, 2005K052872IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A
Taidoc Technology Corporation, TW
DXN
Nov 22, 2005K052784DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
Welch Allyn, Inc.
DXN
Nov 18, 2005K051149MEDITECH MODEL ABPM-04
Meditech Kft., IL
DXN
Oct 28, 2005K050233OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI
Omron Healthcare, Inc.
DXN
Oct 19, 2005K052046BLOOD PRESSURE METER, MODEL CH-432
Citizen Watch Co., Ltd.
DXN
Sep 14, 2005K051366PICONIBP OEM MODULE
Philips Medizin Systeme Boeblingen GmbH, DE
DXN
Sep 12, 2005K051565PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA
Proton Healthcare , Ltd.
DXN
Sep 8, 2005K052154OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
Omron Healthcare, Inc.
DXN
Sep 8, 2005K052153OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
Omron Healthcare, Inc.
DXN
Aug 23, 2005K051862PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR.
Ya Horng Electronic Co., Ltd., TW
DXN
Aug 19, 2005K051863AMLUCK, YA HORNG
Ya Horng Electronic Co., Ltd., TW
DXN

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