Medical Device Manufacturer · CN , Shenzhen

Edan Instruments, Inc.

92 submissions · 92 cleared · Since 2004
92
Total
92
Cleared
0
Denied

Edan Instruments, Inc. — FDA 510(k) Submissions

Edan Instruments, Inc. has submitted 92 FDA 510(k) premarket notifications since 2004, of which 92 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrocardiograph, Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), System, Imaging, Pulsed Doppler, Ultrasonic, System, Monitoring, Perinatal, System, Imaging, Pulsed Echo, Ultrasonic . Use the specialty filter in the sidebar to narrow results.

92 devices
1–25 of 92
Holter ECG and ABP system (HolterABP)
K251591 · DQK Computer, Diagnostic,... · Cardiovascular
Feb 2026 262d
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
K251268 · IYN System, Imaging, Pulsed... · Radiology
Dec 2025 243d
Fetal & Maternal Monitor (F15A, F15A Air)
K241882 · HGM System, Monitoring,... · Obstetrics & Gynecology
Aug 2025 425d
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
K250179 · MHX Monitor, Physiological,... · Cardiovascular
Jul 2025 188d
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
K250214 · IYN System, Imaging, Pulsed... · Radiology
Feb 2025 27d
Patient Monitor (RespArray)
K240320 · MHX Monitor, Physiological,... · Cardiovascular
Jun 2024 147d
Stimulation System (PA series, PR series, S series and Q series)
K232786 · IPF Stimulator, Muscle, Powered · Physical Medicine
May 2024 248d
Patient Monitor (iX10, iX12, iX15)
K232962 · MHX Monitor, Physiological,... · Cardiovascular
Apr 2024 211d
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
K233038 · MWI Monitor, Physiological,... · Cardiovascular
Mar 2024 165d
Central Monitoring System (MFM-CMS)
K232694 · MHX Monitor, Physiological,... · Cardiovascular
Feb 2024 153d
Holter ECG and ABP System
K230184 · DSH Recorder, Magnetic Tape,... · Cardiovascular
Sep 2023 245d
Electrocardiograph: SE-1200 Pro and SE-1201 Pro
K222902 · DPS Electrocardiograph · Cardiovascular
Jul 2023 308d
Patient Monitor: RespArray
K220308 · MHX Monitor, Physiological,... · Cardiovascular
Aug 2022 190d
Electrocardiograph
K212278 · DPS Electrocardiograph · Cardiovascular
Apr 2022 261d
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
K210139 · DXN System, Measurement,... · Cardiovascular
Oct 2021 255d
electrocardiograph: SE-1202
K210140 · DPS Electrocardiograph · Cardiovascular
Oct 2021 255d
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
K202892 · MWI Monitor, Physiological,... · Cardiovascular
Jan 2021 122d
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
K202856 · IYN System, Imaging, Pulsed... · Radiology
Jan 2021 119d
Patient Monitor
K202336 · MHX Monitor, Physiological,... · Cardiovascular
Jan 2021 159d
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System
K192879 · IYN System, Imaging, Pulsed... · Radiology
May 2020 234d
Patient Monitor
K192514 · MHX Monitor, Physiological,... · Cardiovascular
Apr 2020 203d
Diagnostic Ultrasound System
K192791 · IYO System, Imaging, Pulsed... · Radiology
Nov 2019 58d
Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System
K190186 · IYO System, Imaging, Pulsed... · Radiology
Mar 2019 55d
vital signs monitor
K180380 · DQA Oximeter · Cardiovascular
Dec 2018 312d
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
K173042 · HGM System, Monitoring,... · Obstetrics & Gynecology
Aug 2018 336d

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