15 results · 79ms · Sources: EU EUDAMED, US FDA

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IHEALTH

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code NBW·November 27, 2025

IHEALTH CONTINUOUS MONITORING DEVICE

FDA Adverse Event
Death ·ANDON HEALTH CO., LTD·Product code DXN·April 19, 2024

IHEALTH

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code DXN·July 30, 2025

IHEALTH_BP5S

FDA Adverse Event
Death ·ANDON HEALTH CO., LTD.·Product code DXN·April 19, 2024

IHEALTH

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code DXN·April 16, 2025

INFRARED NO-TOUCH FOREHEAD THERMOMETER

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code FLL·April 25, 2023

IHEALTH

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code DXN·April 16, 2025

IHEALTH

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code DXN·April 16, 2025

IHEALTH

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code DXN·April 16, 2025

IHEALTH

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code QKP·April 18, 2025

CONNEQT PULSE

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code DXN·April 16, 2025

IHEALTH

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code DXN·April 16, 2025

MEDLINE

FDA Adverse Event
Malfunction ·ANDON HEALTH CO., LTD.·Product code DXN·March 10, 2026

BG5 SMART / IHEALTHLAB

FDA Adverse Event
Malfunction ·ANDON HEALTH CO. LTD.·Product code NBW·September 12, 2019

I HEALTH COVID TEST KIT

FDA Adverse Event
Malfunction ·I HEALTH LABS., INC. / ANDON MEDICAL CO., LTD.·Product code QKP·August 29, 2022