Edan Instruments, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Telemetry Monitor (iT30, iT50), SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E), Holter ECG and ABP system (HolterABP)
94
Total
94
Cleared
0
Denied
FDA 510(k) Regulatory Record - Edan Instruments, Inc. Cardiovascular ✕
44 devices
Cleared
Aug 06, 2026
Telemetry Monitor (iT30, iT50)
Cardiovascular
447d
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
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
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