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)
Top companies in DXN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2025 | PYRAMES INC Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 Open, Classified |
DXN | K223873 |
| Oct 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. Open, Classified |
DXN | K193627 |
| Oct 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. Open, Classified |
DXN | K193627 |
| Oct 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 Open, Classified |
DXN | K193627 |
| Apr 10, 2024 | Baxter 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 |
DXN | None listed |
| Apr 10, 2024 | Baxter 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 |
DXN | None listed |
| Apr 10, 2024 | Baxter 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 |
DXN | K101680 |
| Apr 1, 2024 | MEDLINE INDUSTRIES, LP - Northfield Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS Open, Classified |
DXN | K193627 |
| May 17, 2021 | Mediana 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 |
DXN | K200434 |
| Apr 22, 2021 | Welch 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 |
DXN | K101680 |
| Apr 22, 2021 | Welch Allyn Inc GS777 Wall Transformer
Model: 77710
Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings. Terminated |
DXN | None listed |
| May 15, 2020 | Mediana 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 |
DXN | K170497 |
| Apr 20, 2020 | Suntech Medical, Inc. Oscar 2, Model 250 System Terminated |
DXN | K151520 |
| Dec 11, 2019 | Suntech 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 |
DXN | K151520 |
| May 21, 2019 | Edwards 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 |
DXN | K160552 |
| Jun 11, 2018 | Withings Sas Nokia BPM+ Wireless Blood Pressure Monitor
Product System, measurement, blood-pressure, non-invasive Completed |
DXN | K133125 |
| Feb 27, 2017 | Welch 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 |
DXN | K152770 |
| Sep 12, 2016 | A & 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 |
DXN | K043217 |
| Jun 9, 2015 | Edwards 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 |
DXN | K140312 |
| Feb 14, 2013 | Philips 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 |
DXN | K112652 |
| Aug 30, 2012 | Philips 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 |
DXN | K112652 |
| Aug 6, 2012 | FMS, 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 |
DXN | K023338 |
| Nov 29, 2011 | Del 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 |
DXN | K103732 |
| Aug 3, 2010 | Zoe 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 |
DXN | K040012 |
| Apr 15, 2010 | Mindray 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 |
DXN | K091068 |
| Sep 18, 2009 | Physio 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 |
DXN | K082937 |
| Aug 25, 2008 | Smiths Medical PM, Inc. BCI Non Invasive Blood Pressure Monitor
Product/Catalog number 6004, Terminated |
DXN | K031742 K970801 +2 |
| Sep 21, 2005 | Becton Dickinson Medical Systems BD DTX Plus, Custom dual-line pressure monitoring kit. Terminated |
DXN | K935782 |
| Sep 21, 2005 | Becton Dickinson Medical Systems BD DTX Plus, Custom triple-line pressure monitoring kit. Terminated |
DXN | K935782 |
| Sep 21, 2005 | Becton Dickinson Medical Systems BD DTX Plus, Custom single-line pressure monitoting kit. Terminated |
DXN | K935782 |
| Sep 21, 2005 | Becton Dickinson Medical Systems BD DTX Plus, Custom single-line neonatal pressure monitoring kit. Terminated |
DXN | K935782 |
| Sep 21, 2005 | Becton Dickinson Medical Systems BD DTX Plus, 12'' single-line neonatal pressure monitoring kit. Terminated |
DXN | K935782 |
| Sep 21, 2005 | Becton Dickinson Medical Systems BD DTX Plus, Stand-alone pressure transducer with 3cc/hr flush device Terminated |
DXN | K935782 |
| Sep 21, 2005 | Becton Dickinson Medical Systems BD DTX Plus, 72'' complete single-line pressure monitoring kit. Terminated |
DXN | K935782 |
| Sep 21, 2005 | Becton Dickinson Medical Systems BD DTX Plus, 60'' complete dual-line pressure monitoring kit. Terminated |
DXN | K935782 |
| Sep 21, 2005 | Becton Dickinson Medical Systems BD DTX Plus, 60'' complete single-line pressure monitoring kit. Terminated |
DXN | K935782 |
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