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Edan Instruments, Inc.

FDA 510(k) & PMA Approved Devices — 48 products

Total Devices48
Categories13
Latest Approval2026-02-09
TypeNumberDevice NameCodeDate
510(k) K251591 Holter ECG and ABP system (HolterABP) DQK 2026-02-09 View
510(k) K251268 Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) IYN 2025-12-23 View
510(k) K241882 Fetal & Maternal Monitor (F15A, F15A Air) HGM 2025-08-27 View
510(k) K250179 Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) MHX 2025-07-29 View
510(k) K250214 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) IYN 2025-02-20 View
510(k) K240320 Patient Monitor (RespArray) MHX 2024-06-28 View
510(k) K232786 Stimulation System (PA series, PR series, S series and Q series) IPF 2024-05-16 View
510(k) K232962 Patient Monitor (iX10, iX12, iX15) MHX 2024-04-19 View
510(k) K233038 Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s MWI 2024-03-08 View
510(k) K232694 Central Monitoring System (MFM-CMS) MHX 2024-02-05 View
510(k) K230184 Holter ECG and ABP System DSH 2023-09-25 View
510(k) K222902 Electrocardiograph: SE-1200 Pro and SE-1201 Pro DPS 2023-07-28 View
510(k) K220308 Patient Monitor: RespArray MHX 2022-08-11 View
510(k) K212278 Electrocardiograph DPS 2022-04-07 View
510(k) K210140 electrocardiograph: SE-1202 DPS 2021-10-01 View
510(k) K210139 Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 DXN 2021-10-01 View
510(k) K202892 Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s MWI 2021-01-28 View
510(k) K202856 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 IYN 2021-01-25 View
510(k) K202336 Patient Monitor MHX 2021-01-23 View
510(k) K192879 Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System IYN 2020-05-21 View
510(k) K192514 Patient Monitor MHX 2020-04-02 View
510(k) K192791 Diagnostic Ultrasound System IYO 2019-11-27 View
510(k) K190186 Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System IYO 2019-03-28 View
510(k) K180380 vital signs monitor DQA 2018-12-21 View
510(k) K173042 Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 HGM 2018-08-30 View
510(k) K172780 SD1 Ultrasonic Pocket Doppler KNG 2018-06-06 View
510(k) K180862 Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System IYN 2018-05-24 View
510(k) K180408 U60 Diagnostic Ultrasound System IYN 2018-04-13 View
510(k) K171942 Electrocardiograph DPS 2018-01-24 View
510(k) K173003 U50 Diagnostic Ultrasound System IYN 2017-11-15 View
510(k) K172380 U2 Diagnostic Ultrasound System IYN 2017-09-29 View
510(k) K171943 Electrocardiograph DPS 2017-09-25 View
510(k) K171178 Central Monitoring System HGM 2017-09-06 View
510(k) K171900 Acclarix AX4 Diagnostic Ultrasound System IYN 2017-08-18 View
510(k) K171824 Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System IYO 2017-07-18 View
510(k) K170995 Electrocardiograph DPS 2017-06-02 View
510(k) K160876 PC ECG DPS 2017-02-15 View
510(k) K161056 Telemetry Transmitter MHX 2017-02-03 View
510(k) K162055 Acclarix LX8 Diagnostic Ultrasound System IYN 2017-01-31 View
510(k) K160981 Patient Monitor MHX 2016-12-22 View
510(k) K151978 EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control CHL 2016-07-15 View
510(k) K161302 PC ECG DPS 2016-07-01 View
510(k) K161300 Acclarix AX8 Diagnostic Ultrasound System IYO 2016-05-31 View
510(k) K152552 Patient Monitor MHX 2016-04-29 View
510(k) K160790 Acclarix LX8 Diagnostic Ultrasound System IYN 2016-04-04 View
510(k) K152427 PC ECG DPS 2016-02-05 View
510(k) K153475 SD5 & SD6 Ultrasonic Tabletop Doppler KNG 2016-01-29 View
510(k) K151787 Holter System DQK 2016-01-27 View
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