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)
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Top companies in DXN

DateFirm and productCodeLinked 510(k)
Apr 2, 2025PYRAMES INC
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Open, Classified
DXNK223873
Oct 8, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Open, Classified
DXNK193627
Oct 8, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Open, Classified
DXNK193627
Oct 8, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Open, Classified
DXNK193627
Apr 10, 2024Baxter Healthcare Corporation
Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012
Open, Classified
DXNNone listed
Apr 10, 2024Baxter Healthcare Corporation
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPO
Open, Classified
DXNNone listed
Apr 10, 2024Baxter Healthcare Corporation
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP,
Open, Classified
DXNK101680
Apr 1, 2024MEDLINE INDUSTRIES, LP - Northfield
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Open, Classified
DXNK193627
May 17, 2021Mediana Co., Ltd.
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for a
Terminated
DXNK200434
Apr 22, 2021Welch Allyn Inc
ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonate
Terminated
DXNK101680
Apr 22, 2021Welch Allyn Inc
GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings.
Terminated
DXNNone listed
May 15, 2020Mediana Co., Ltd.
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate
Terminated
DXNK170497
Apr 20, 2020Suntech Medical, Inc.
Oscar 2, Model 250 System
Terminated
DXNK151520
Dec 11, 2019Suntech Medical, Inc.
Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-
Terminated
DXNK151520
May 21, 2019Edwards Lifesciences, LLC
EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sen
Terminated
DXNK160552
Jun 11, 2018Withings Sas
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
Completed
DXNK133125
Feb 27, 2017Welch Allyn Inc
Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Co
Terminated
DXNK152770
Sep 12, 2016A & D Enginering Inc
Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse r
Terminated
DXNK043217
Jun 9, 2015Edwards Lifesciences, LLC
ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Terminated
DXNK140312
Feb 14, 2013Philips Healthcare Inc.
Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitorin
Terminated
DXNK112652
Aug 30, 2012Philips Healthcare Inc.
Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and
Terminated
DXNK112652
Aug 6, 2012FMS, Finapres Medical Systems BV
Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be us
Terminated
DXNK023338
Nov 29, 2011Del Mar Reynolds Medical, Ltd.
Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate m
Terminated
DXNK103732
Aug 3, 2010Zoe Medical Incorporated
The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on
Terminated
DXNK040012
Apr 15, 2010Mindray DS USA, Inc., dba Datascope Patient Monitoring
SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 2
Terminated
DXNK091068
Sep 18, 2009Physio Control, Inc.
Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It o
Terminated
DXNK082937
Aug 25, 2008Smiths Medical PM, Inc.
BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,
Terminated
DXNK031742
K970801 +2
Sep 21, 2005Becton Dickinson Medical Systems
BD DTX Plus, Custom dual-line pressure monitoring kit.
Terminated
DXNK935782
Sep 21, 2005Becton Dickinson Medical Systems
BD DTX Plus, Custom triple-line pressure monitoring kit.
Terminated
DXNK935782
Sep 21, 2005Becton Dickinson Medical Systems
BD DTX Plus, Custom single-line pressure monitoting kit.
Terminated
DXNK935782
Sep 21, 2005Becton Dickinson Medical Systems
BD DTX Plus, Custom single-line neonatal pressure monitoring kit.
Terminated
DXNK935782
Sep 21, 2005Becton Dickinson Medical Systems
BD DTX Plus, 12'' single-line neonatal pressure monitoring kit.
Terminated
DXNK935782
Sep 21, 2005Becton Dickinson Medical Systems
BD DTX Plus, Stand-alone pressure transducer with 3cc/hr flush device
Terminated
DXNK935782
Sep 21, 2005Becton Dickinson Medical Systems
BD DTX Plus, 72'' complete single-line pressure monitoring kit.
Terminated
DXNK935782
Sep 21, 2005Becton Dickinson Medical Systems
BD DTX Plus, 60'' complete dual-line pressure monitoring kit.
Terminated
DXNK935782
Sep 21, 2005Becton Dickinson Medical Systems
BD DTX Plus, 60'' complete single-line pressure monitoring kit.
Terminated
DXNK935782

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