Andon Health Co, Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Andon Health Co, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: iHealth Compare Wireless Blood Pressure Monitor(BP-300C), iHealth® Early Pregnancy Test, Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA)
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.
2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Andon Health Co, Ltd.
92 devices
Cleared
CT
Aug 04, 2025
iHealth Compare Wireless Blood Pressure Monitor(BP-300C)
Cardiovascular
115d
Cleared
Dec 20, 2024
iHealth® Early Pregnancy Test
Chemistry
218d
Cleared
Apr 22, 2024
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA)
Cardiovascular
123d
Cleared
Feb 15, 2023
Arm Blood Pressure Monitor
Cardiovascular
146d
Cleared
Dec 21, 2022
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
Neurology
90d
Cleared
Jan 28, 2022
iHealth infrared Ear thermometer PT5
General Hospital
165d
Cleared
Jul 30, 2021
Wrist Blood Pressure Monitor, Blood Pressure Monitor
Cardiovascular
137d
Cleared
Jul 29, 2021
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
Cardiovascular
136d
Cleared
Mar 08, 2021
iHealth Wireless No-Touch Forehead Thermometer
General Hospital
168d
Cleared
Jan 05, 2021
iHealth Clinical Digital Thermometer
General Hospital
105d
Cleared
Oct 07, 2020
Livocare Surgical Mask
General Hospital
134d
Cleared
Oct 01, 2020
Infrared PT2L Digital No-Touch Thermometer
General Hospital
197d
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