Edan Instruments, Inc. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Edan Instruments, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E), Holter ECG and ABP system (HolterABP), Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
93
Total
93
Cleared
0
Denied
Edan Instruments, Inc. has 93 FDA 510(k) cleared medical devices. Based in Shenzhen, CN.
Latest FDA clearance: Jul 2026. Active since 2004. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Edan Instruments, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Edan Medical, Underwriters Laboratories, Inc. and Regulatory Technology Services, LLC.
FDA 510(k) Regulatory Record - Edan Instruments, Inc.
93 devices
Cleared
Jul 02, 2026
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
Cardiovascular
330d
Cleared
Feb 09, 2026
Holter ECG and ABP system (HolterABP)
Cardiovascular
262d
Cleared
Dec 23, 2025
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
Radiology
243d
Cleared
Aug 27, 2025
Fetal & Maternal Monitor (F15A, F15A Air)
Obstetrics & Gynecology
425d
Cleared
Jul 29, 2025
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
Cardiovascular
188d
Cleared
Feb 20, 2025
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7,...
Radiology
27d
Cleared
Jun 28, 2024
Patient Monitor (RespArray)
Cardiovascular
147d
Cleared
May 16, 2024
Stimulation System (PA series, PR series, S series and Q series)
Physical Medicine
248d
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
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