Edan Instruments, Inc.
FDA 510(k) & PMA Approved Devices — 50 products
Total Devices50
Categories13
Latest FDA decision2026-08-06
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251508 | Telemetry Monitor (iT30, iT50) | MHX | 2026-08-06 | View |
| 510(k) | K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | DPS | 2026-07-02 | View |
| 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 |
No matching devices.
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