Medical Device Manufacturer · CN , Tiajin

Andon Health Co, Ltd. - FDA 510(k) Cleared Devices

92 submissions · 92 cleared · Since 2008
92
Total
92
Cleared
0
Denied

Andon Health Co, Ltd. has 92 FDA 510(k) cleared cardiovascular devices. Based in Tiajin, CN.

Latest FDA clearance: Aug 2025. Active since 2008.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

92 devices
1–12 of 92
iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr
K251113 · DXN System, Measurement, Blood-pressure, Non-invasive · Cardiovascular
Aug 2025 115d
iHealth? Early Pregnancy Test; iHealth? Early Pregnancy Test Strip
K241394 · LCX Kit, Test, Pregnancy, Hcg, Over The Counter · Chemistry
Dec 2024 218d
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)
K234041 · DXN System, Measurement, Blood-pressure, Non-invasive · Cardiovascular
Apr 2024 123d
Arm Blood Pressure Monitor
K222869 · DXN System, Measurement, Blood-pressure, Non-invasive · Cardiovascular
Feb 2023 146d
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
K222867 · NUH Stimulator, Nerve, Transcutaneous, Over-the-counter · Neurology
Dec 2022 90d
iHealth infrared Ear thermometer PT5
K212598 · FLL Continuous Measurement Thermometer · General Hospital
Jan 2022 165d
Wrist Blood Pressure Monitor, Blood Pressure Monitor
K210768 · DXN System, Measurement, Blood-pressure, Non-invasive · Cardiovascular
Jul 2021 137d
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
K210770 · DXN System, Measurement, Blood-pressure, Non-invasive · Cardiovascular
Jul 2021 136d
iHealth Wireless No-Touch Forehead Thermometer
K202753 · FLL Continuous Measurement Thermometer · General Hospital
Mar 2021 168d
iHealth Clinical Digital Thermometer
K202791 · FLL Continuous Measurement Thermometer · General Hospital
Jan 2021 105d
Livocare Surgical Mask
K201380 · FXX Mask, Surgical · General Hospital
Oct 2020 134d
Infrared PT2L Digital No-Touch Thermometer
K200710 · FLL Continuous Measurement Thermometer · General Hospital
Oct 2020 197d

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All92 Cardiovascular 72 Chemistry 9 General Hospital 6 Neurology 2 Anesthesiology 2 Gastroenterology & Urology 1