Medical Device Manufacturer · CN , Shenzhen

Edan Instruments, Inc. - FDA 510(k) Cleared Devices

92 submissions · 92 cleared · Since 2004

Official Website

92

Total

92

Cleared

0

Denied

FDA 510(k) cleared devices by Edan Instruments, Inc. Cardiovascular ✕

42 devices

1-12 of 42

Cleared Feb 09, 2026

Holter ECG and ABP system (HolterABP)

Cardiovascular · 262d

Cleared Jul 29, 2025

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

Cardiovascular · 188d

Cleared Jun 28, 2024

Patient Monitor (RespArray)

Cardiovascular · 147d

Cleared Apr 19, 2024

Patient Monitor (iX10, iX12, iX15)

Cardiovascular · 211d

Cleared Mar 08, 2024

Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s

Cardiovascular · 165d

Cleared Feb 05, 2024

Central Monitoring System (MFM-CMS)

Cardiovascular · 153d

Cleared Sep 25, 2023

Holter ECG and ABP System

Cardiovascular · 245d

Cleared Jul 28, 2023

Electrocardiograph: SE-1200 Pro and SE-1201 Pro

Cardiovascular · 308d

Cleared Aug 11, 2022

Patient Monitor: RespArray

Cardiovascular · 190d

Cleared Apr 07, 2022

Electrocardiograph

Cardiovascular · 261d

Cleared Oct 01, 2021

Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09

Cardiovascular · 255d

Cleared Oct 01, 2021

electrocardiograph: SE-1202

Cardiovascular · 255d

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