| 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) | Andon Health Co, Ltd. | 2025-08-04 |
| iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (K241394) | Andon Health Co, Ltd. | 2024-12-20 |
| 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) | Andon Health Co, Ltd. | 2024-04-22 |
| Arm Blood Pressure Monitor (K222869) | Andon Health Co, Ltd. | 2023-02-15 |
| AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) (K222867) | Andon Health Co, Ltd. | 2022-12-21 |
| iHealth infrared Ear thermometer PT5 (K212598) | Andon Health Co, Ltd. | 2022-01-28 |
| Wrist Blood Pressure Monitor, Blood Pressure Monitor (K210768) | Andon Health Co, Ltd. | 2021-07-30 |
| Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor (K210770) | Andon Health Co, Ltd. | 2021-07-29 |
| iHealth Wireless No-Touch Forehead Thermometer (K202753) | Andon Health Co, Ltd. | 2021-03-08 |
| iHealth Clinical Digital Thermometer (K202791) | Andon Health Co, Ltd. | 2021-01-05 |
| Livocare Surgical Mask (K201380) | Andon Health Co, Ltd. | 2020-10-07 |
| Infrared PT2L Digital No-Touch Thermometer (K200710) | Andon Health Co, Ltd. | 2020-10-01 |
| iHealth Infrared No-Touch Forehead Thermometer (K200531) | Andon Health Co, Ltd. | 2020-07-15 |
| Fully Automatic Electronic Blood Pressure Monitor (K183535) | Andon Health Co, Ltd. | 2019-06-04 |
| Fully Automatic Electronic Blood Pressure Monitor (K183534) | Andon Health Co, Ltd. | 2019-05-16 |
| Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK (K181541) | Andon Health Co, Ltd. | 2019-04-16 |
| iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) (K181070) | Andon Health Co, Ltd. | 2019-02-01 |
| Portable ECG Monitor (ECG3) (K172862) | Andon Health Co, Ltd. | 2018-07-24 |
| iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) (K170231) | Andon Health Co, Ltd. | 2017-09-15 |
| BP5S Wireless Blood Pressure Monitor (K171062) | Andon Health Co, Ltd. | 2017-08-01 |
| Fully Automatic Blood Pressure Monitor (K171282) | Andon Health Co, Ltd. | 2017-07-27 |
| Fully Automatic Electronic Blood Pressure Monitor (K163276) | Andon Health Co, Ltd. | 2017-05-11 |
| AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System (K153561) | Andon Health Co, Ltd. | 2017-02-16 |
| Fully Automatic Electronic Blood Pressure Monitor (K162668) | Andon Health Co, Ltd. | 2017-02-14 |
| Fully Automatic Electronic Blood Pressure Monitor (K162915) | Andon Health Co, Ltd. | 2017-02-08 |
| iHealth Wireless Blood Pressure Monitor (K162144) | Andon Health Co, Ltd. | 2017-02-01 |
| iHealth Align Gluco-Monitoring system (K153286) | Andon Health Co, Ltd. | 2016-08-19 |
| Wireless Smart Gluco-Monitoring System (K153278) | Andon Health Co, Ltd. | 2016-08-19 |
| Fully Automatic Electronic Blood Pressure Monitor (K160565) | Andon Health Co, Ltd. | 2016-08-10 |
| Fully Automatic Electronic Blood Pressure Monitor (K160563) | Andon Health Co, Ltd. | 2016-08-04 |
| iHealth Track Blood Pressure Monitor (K160014) | Andon Health Co, Ltd. | 2016-02-02 |
| iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System (K150833) | Andon Health Co, Ltd. | 2015-12-04 |
| iHealth BP3L Wireless Blood Pressure Monitor (K152003) | Andon Health Co, Ltd. | 2015-09-24 |
| iHealth View BP7S Wireless Blood Pressure Wrist Monitor (K152379) | Andon Health Co, Ltd. | 2015-09-23 |
| Fully Automatic Electronic Blood Pressure Monitor (K151460) | Andon Health Co, Ltd. | 2015-09-08 |
| Transcutaneous Electrical Nerve Stimulators (TENS) (K150043) | Andon Health Co, Ltd. | 2015-08-14 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K141984) | Andon Health Co, Ltd. | 2015-04-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K140121) | Andon Health Co, Ltd. | 2014-07-02 |
| IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM (K133790) | Andon Health Co, Ltd. | 2014-05-22 |
| ANDON BLOOD PRESSURE CUFF (K133117) | Andon Health Co, Ltd. | 2014-03-04 |
| IHEALTH FINGERTIP PULSE OXIMETER (K131111) | Andon Health Co, Ltd. | 2013-09-11 |
| IHEALTH CLOUD (K131203) | Andon Health Co, Ltd. | 2013-07-19 |
| APPS-HEALTH01 (K122098) | Andon Health Co, Ltd. | 2013-03-21 |
| FINGERTIP PULSE OXIMETER (K121697) | Andon Health Co, Ltd. | 2012-10-15 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K121372) | Andon Health Co, Ltd. | 2012-09-10 |
| WI-FI BODY SCALE (K120896) | Andon Health Co, Ltd. | 2012-07-26 |
| FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR (K121470) | Andon Health Co, Ltd. | 2012-06-14 |
| KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR (K120672) | Andon Health Co, Ltd. | 2012-06-01 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO (K111830) | Andon Health Co, Ltd. | 2011-12-09 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K111826) | Andon Health Co, Ltd. | 2011-12-09 |
| ACG-8511 PORTABLE ECG MONITOR (K110328) | Andon Health Co, Ltd. | 2011-07-15 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K110018) | Andon Health Co, Ltd. | 2011-03-15 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 (K102939) | Andon Health Co, Ltd. | 2011-02-23 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K110330) | Andon Health Co, Ltd. | 2011-02-18 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102690) | Andon Health Co, Ltd. | 2010-11-24 |
| KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102631) | Andon Health Co, Ltd. | 2010-11-04 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102930) | Andon Health Co, Ltd. | 2010-11-03 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102906) | Andon Health Co, Ltd. | 2010-10-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 (K102356) | Andon Health Co, Ltd. | 2010-09-20 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 (K102353) | Andon Health Co, Ltd. | 2010-09-17 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 (K101950) | Andon Health Co, Ltd. | 2010-08-31 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 (K101010) | Andon Health Co, Ltd. | 2010-07-30 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 (K100940) | Andon Health Co, Ltd. | 2010-06-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 (K100014) | Andon Health Co, Ltd. | 2010-01-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903 (K092811) | Andon Health Co, Ltd. | 2010-01-13 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 (K092588) | Andon Health Co, Ltd. | 2009-12-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 (K092510) | Andon Health Co, Ltd. | 2009-12-23 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 (K093452) | Andon Health Co, Ltd. | 2009-12-23 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 (K093528) | Andon Health Co, Ltd. | 2009-12-04 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 (K093387) | Andon Health Co, Ltd. | 2009-11-27 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 (K091737) | Andon Health Co, Ltd. | 2009-08-18 |
| SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD (K091738) | Andon Health Co, Ltd. | 2009-08-18 |
| SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 (K091739) | Andon Health Co, Ltd. | 2009-08-18 |
| MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 (K091500) | Andon Health Co, Ltd. | 2009-07-31 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 (K091997) | Andon Health Co, Ltd. | 2009-07-30 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 (K092045) | Andon Health Co, Ltd. | 2009-07-30 |
| FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 (K090772) | Andon Health Co, Ltd. | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 (K090770) | Andon Health Co, Ltd. | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 (K090771) | Andon Health Co, Ltd. | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 (K090769) | Andon Health Co, Ltd. | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, (K090768) | Andon Health Co, Ltd. | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 (K090963) | Andon Health Co, Ltd. | 2009-04-30 |
| SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 (K083395) | Andon Health Co, Ltd. | 2009-02-27 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 (K083319) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 (K083318) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 (K083246) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 (K083317) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 (K083247) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 (K083248) | Andon Health Co, Ltd. | 2009-01-29 |
| KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K080326) | Andon Health Co, Ltd. | 2008-07-31 |
| AG-605 BLOOD GLUCOSE MONITORING SYSTEM (K073030) | Andon Health Co, Ltd. | 2008-07-21 |
| KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K080319) | Andon Health Co, Ltd. | 2008-07-02 |