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Edan Instruments, Inc.

FDA 510(k) & PMA Approved Devices — 50 products

Total Devices50
Categories13
Latest FDA decision2026-08-06
TypeNumberDevice NameCodeDateActions
510(k) K202336 Patient MonitorMHX2021-01-23 View
510(k) K192879 Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound SystemIYN2020-05-21 View
510(k) K192514 Patient MonitorMHX2020-04-02 View
510(k) K192791 Diagnostic Ultrasound SystemIYO2019-11-27 View
510(k) K190186 Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemIYO2019-03-28 View
510(k) K180380 vital signs monitorDQA2018-12-21 View
510(k) K173042 Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3HGM2018-08-30 View
510(k) K172780 SD1 Ultrasonic Pocket DopplerKNG2018-06-06 View
510(k) K180862 Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemIYN2018-05-24 View
510(k) K180408 U60 Diagnostic Ultrasound SystemIYN2018-04-13 View
510(k) K171942 ElectrocardiographDPS2018-01-24 View
510(k) K173003 U50 Diagnostic Ultrasound SystemIYN2017-11-15 View
510(k) K172380 U2 Diagnostic Ultrasound SystemIYN2017-09-29 View
510(k) K171943 ElectrocardiographDPS2017-09-25 View
510(k) K171178 Central Monitoring SystemHGM2017-09-06 View
510(k) K171900 Acclarix AX4 Diagnostic Ultrasound SystemIYN2017-08-18 View
510(k) K171824 Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemIYO2017-07-18 View
510(k) K170995 ElectrocardiographDPS2017-06-02 View
510(k) K160876 PC ECGDPS2017-02-15 View
510(k) K161056 Telemetry TransmitterMHX2017-02-03 View

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