Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

93 results for "Andon Health Co, Ltd."
1–24 of 93
Search insights Median review: 115d Cleared: 100% Top manufacturer: Andon Health Co, Ltd. Lead specialty: Cardiovascular
Cleared CT Aug 04, 2025
iHealth Compare Wireless Blood Pressure Monitor(BP-300C)
K251113 · DXN
Andon Health Co, Ltd.
Cardiovascular · 115d
Cleared Dec 20, 2024
iHealth® Early Pregnancy Test
K241394 · LCX
Andon Health Co, Ltd.
Chemistry · 218d
Cleared Apr 22, 2024
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA)
K234041 · DXN
Andon Health Co, Ltd.
Cardiovascular · 123d
Cleared Feb 15, 2023
Arm Blood Pressure Monitor
K222869 · DXN
Andon Health Co, Ltd.
Cardiovascular · 146d
Cleared Dec 21, 2022
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
K222867 · NUH
Andon Health Co, Ltd.
Neurology · 90d
Cleared Jan 28, 2022
iHealth infrared Ear thermometer PT5
K212598 · FLL
Andon Health Co, Ltd.
General Hospital · 165d
Cleared Jul 30, 2021
Wrist Blood Pressure Monitor, Blood Pressure Monitor
K210768 · DXN
Andon Health Co, Ltd.
Cardiovascular · 137d
Cleared Jul 29, 2021
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
K210770 · DXN
Andon Health Co, Ltd.
Cardiovascular · 136d
Cleared Mar 08, 2021
iHealth Wireless No-Touch Forehead Thermometer
K202753 · FLL
Andon Health Co, Ltd.
General Hospital · 168d
Cleared Jan 12, 2021
Disposable Medical Surgical Mask
K201625 · FXX
Tianjin Saiyuan Technology Co., Ltd.
General Hospital · 211d
Cleared Jan 05, 2021
iHealth Clinical Digital Thermometer
K202791 · FLL
Andon Health Co, Ltd.
General Hospital · 105d
Cleared Oct 07, 2020
Livocare Surgical Mask
K201380 · FXX
Andon Health Co, Ltd.
General Hospital · 134d
Cleared Oct 01, 2020
Infrared PT2L Digital No-Touch Thermometer
K200710 · FLL
Andon Health Co, Ltd.
General Hospital · 197d
Cleared Jul 15, 2020
iHealth Infrared No-Touch Forehead Thermometer
K200531 · FLL
Andon Health Co, Ltd.
General Hospital · 135d
Cleared Jun 04, 2019
Fully Automatic Electronic Blood Pressure Monitor
K183535 · DXN
Andon Health Co, Ltd.
Cardiovascular · 167d
Cleared May 16, 2019
Fully Automatic Electronic Blood Pressure Monitor
K183534 · DXN
Andon Health Co, Ltd.
Cardiovascular · 148d
Cleared Apr 16, 2019
Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native...
K181541 · MWI
Andon Health Co, Ltd.
Cardiovascular · 309d
Cleared Feb 01, 2019
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
K181070 · NBW
Andon Health Co, Ltd.
Chemistry · 284d
Cleared Jul 24, 2018
Portable ECG Monitor (ECG3)
K172862 · DSH
Andon Health Co, Ltd.
Cardiovascular · 307d
Cleared Sep 15, 2017
iHealth Align Gluco-Monitoring System (BG1)
K170231 · NBW
Andon Health Co, Ltd.
Chemistry · 233d
Cleared Aug 01, 2017
BP5S Wireless Blood Pressure Monitor
K171062 · DXN
Andon Health Co, Ltd.
Cardiovascular · 113d
Cleared Jul 27, 2017
Fully Automatic Blood Pressure Monitor
K171282 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared CT May 11, 2017
Fully Automatic Electronic Blood Pressure Monitor
K163276 · DXN
Andon Health Co, Ltd.
Cardiovascular · 171d
Cleared Feb 16, 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose...
K153561 · NBW
Andon Health Co, Ltd.
Chemistry · 430d