Home › Device types › DXN
System, Measurement, Blood-Pressure, Non-Invasive
FDA product code DXN · Class 2 · Cardiovascular
4,829
Registered devices
3,169
Adverse events
36
Recalls
1,221
510(k) clearances
Devices with this code
HemoSphere Vita — Edwards Lifesciences LLCAlphaMed — Shenzhen Urion Technology Co., LtdTango M2 — SUNTECH MEDICAL, INC.SunTech — SUNTECH MEDICAL, INC.PORT — Shenzhen Urion Technology Co., LtdKONQUEST — KONQUEST GROUP INCAdvantage™ — AMERICAN DIAGNOSTIC CORPAdviewII™ — AMERICAN DIAGNOSTIC CORPBlood Pressure Monitor — Omron Healthcare, Inc.QardioArm — QARDIO, INC.Greater Goods — Greater GoodsCeras Health — Ceras Health IncDrKumo — Shenzhen Urion Technology Co., LtdALPHAMED — Shenzhen Urion Technology Co., LtdBENECEN — Guangdong Transtek Medical Electronics Co.,Ltdparamed — SILEX GLOBAL LLCWelch Allyn, Inc. — WELCH ALLYN, INC.Hingmed — Shenzhen Hingmed Medical Instrument Co., Ltd.ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd.CNAP® Monitor 500 — CNSystems Medizintechnik AGCVS — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDArm Type Automatic Blood Pressure Monitor — Shenzhen Jiacom Technology Co., LtdBraun — KAZ USA, INC.TekCare Blood Pressure Monitor — AVITA CORPORATION
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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