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."
25–48 of 93
Search insights Median review: 115d Cleared: 100% Top manufacturer: Andon Health Co, Ltd. Lead specialty: Cardiovascular
Cleared Feb 14, 2017
Fully Automatic Electronic Blood Pressure Monitor
K162668 · DXN
Andon Health Co, Ltd.
Cardiovascular · 141d
Cleared Feb 08, 2017
Fully Automatic Electronic Blood Pressure Monitor
K162915 · DXN
Andon Health Co, Ltd.
Cardiovascular · 114d
Cleared Feb 01, 2017
iHealth Wireless Blood Pressure Monitor
K162144 · DXN
Andon Health Co, Ltd.
Cardiovascular · 184d
Cleared Aug 19, 2016
iHealth Align Gluco-Monitoring system
K153286 · NBW
Andon Health Co, Ltd.
Chemistry · 281d
Cleared Aug 19, 2016
Wireless Smart Gluco-Monitoring System
K153278 · NBW
Andon Health Co, Ltd.
Chemistry · 281d
Cleared Aug 10, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160565 · DXN
Andon Health Co, Ltd.
Cardiovascular · 163d
Cleared Aug 04, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160563 · DXN
Andon Health Co, Ltd.
Cardiovascular · 157d
Cleared Feb 02, 2016
iHealth Track Blood Pressure Monitor
K160014 · DXN
Andon Health Co, Ltd.
Cardiovascular · 29d
Cleared Dec 04, 2015
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart...
K150833 · NBW
Andon Health Co, Ltd.
Chemistry · 249d
Cleared Sep 24, 2015
iHealth BP3L Wireless Blood Pressure Monitor
K152003 · DXN
Andon Health Co, Ltd.
Cardiovascular · 66d
Cleared Sep 23, 2015
iHealth View BP7S Wireless Blood Pressure Wrist Monitor
K152379 · DXN
Andon Health Co, Ltd.
Cardiovascular · 33d
Cleared CT Sep 08, 2015
Fully Automatic Electronic Blood Pressure Monitor
K151460 · DXN
Andon Health Co, Ltd.
Cardiovascular · 99d
Cleared Aug 14, 2015
Transcutaneous Electrical Nerve Stimulators (TENS)
K150043 · NUH
Andon Health Co, Ltd.
Neurology · 217d
Cleared Apr 29, 2015
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K141984 · DXN
Andon Health Co, Ltd.
Cardiovascular · 282d
Cleared Jul 02, 2014
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K140121 · DXN
Andon Health Co, Ltd.
Cardiovascular · 167d
Cleared May 22, 2014
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
K133790 · NBW
Andon Health Co, Ltd.
Chemistry · 164d
Cleared Mar 04, 2014
ANDON BLOOD PRESSURE CUFF
K133117 · DXQ
Andon Health Co, Ltd.
Cardiovascular · 155d
Cleared Sep 11, 2013
IHEALTH FINGERTIP PULSE OXIMETER
K131111 · DQA
Andon Health Co, Ltd.
Anesthesiology · 145d
Cleared Jul 19, 2013
IHEALTH CLOUD
K131203 · DXN
Andon Health Co, Ltd.
Cardiovascular · 81d
Cleared Mar 21, 2013
APPS-HEALTH01
K122098 · DXN
Andon Health Co, Ltd.
Cardiovascular · 248d
Cleared Oct 15, 2012
FINGERTIP PULSE OXIMETER
K121697 · DQA
Andon Health Co, Ltd.
Anesthesiology · 130d
Cleared Sep 10, 2012
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K121372 · DXN
Andon Health Co, Ltd.
Cardiovascular · 126d
Cleared Jul 26, 2012
WI-FI BODY SCALE
K120896 · MNW
Andon Health Co, Ltd.
Gastroenterology & Urology · 122d
Cleared Jun 14, 2012
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
K121470 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d