Edan Instruments, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
92
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251591Holter ECG and ABP system (HolterABP)February 9, 2026
K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)December 23, 2025
K241882Fetal & Maternal Monitor (F15A, F15A Air)August 27, 2025
K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)July 29, 2025
K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, February 20, 2025
K240320Patient Monitor (RespArray)June 28, 2024
K232786Stimulation System (PA series, PR series, S series and Q series)May 16, 2024
K232962Patient Monitor (iX10, iX12, iX15)April 19, 2024
K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sMarch 8, 2024
K232694Central Monitoring System (MFM-CMS)February 5, 2024
K230184Holter ECG and ABP SystemSeptember 25, 2023
K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProJuly 28, 2023
K220308Patient Monitor: RespArrayAugust 11, 2022
K212278ElectrocardiographApril 7, 2022
K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09October 1, 2021
K210140electrocardiograph: SE-1202October 1, 2021
K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sJanuary 28, 2021
K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AJanuary 25, 2021
K202336Patient MonitorJanuary 23, 2021
K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound SystemMay 21, 2020