Home › Device types › DXN
System, Measurement, Blood-Pressure, Non-Invasive
FDA product code DXN · Class 2 · Cardiovascular
4,961
Registered devices
7,287
Adverse events
36
Recalls
1,226
510(k) clearances
Devices with this code
Merit Medical® — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.Omron 10 Series Connected Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc.EV1000 — Edwards Lifesciences LLCABPM-cuff — IEM GmbHWrist Blood Pressure Monitor — GENERATION GUARD PTY LTDLutech — LUTECH INDUSTRIES INCCNAP® Monitor 500 — CNSystems Medizintechnik AGE-Sphyg™ 3 — AMERICAN DIAGNOSTIC CORPPARAMED — SILEX GLOBAL LLCArm Type Automatic Blood Pressure Monitor — Shenzhen Jiacom Technology Co., LtdTeleMate Health — Guangdong Transtek Medical Electronics Co.,LtdTenovi — Tenovi Co.Welch Allyn, Inc. — WELCH ALLYN, INC.3 Series Blood Pressure Monitor — Omron Healthcare, Inc.Bionet — SUNTECH MEDICAL, INC.Electronic Blood Pressure Monitor — Shenzhen Pango Electronic Co., Ltd.Famidoc — Famidoc Technology Co.,Ltd.Sinocare Arm Blood Pressure Monitor — Alicn Medical Shenzhen, Inc.N/A — Shenzhen AOJ Medical Technology Co., LtdBAUM — W. A. BAUM CO., INC.SunTech — SUNTECH MEDICAL, INC.BNC ECG trigger cable,RoHS — SUNTECH MEDICAL, INC.ADVANCED VITAL SIGNS MONITOR — ADVANCED INSTRUMENTATIONS, INC.Beurer — BEURER NORTH AMERICA, L.P.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-24 | PYRAMES INC | Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure |
| 2024-08-30 | MEDLINE INDUSTRIES, LP - Northfield | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the |
| 2024-08-30 | MEDLINE INDUSTRIES, LP - Northfield | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the |
| 2024-08-30 | MEDLINE INDUSTRIES, LP - Northfield | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the |
| 2024-03-26 | Baxter Healthcare Corporation | Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and intern |
| 2024-03-26 | Baxter Healthcare Corporation | Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and intern |
| 2024-03-26 | Baxter Healthcare Corporation | Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and intern |
| 2024-02-26 | MEDLINE INDUSTRIES, LP - Northfield | The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the fir |
| 2021-05-17 | Mediana Co., Ltd. | In some cases the equipment fails to power up and/or key or button unresponsive or not working. |
| 2021-04-22 | Welch Allyn Inc | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock |
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