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Edan Instruments, Inc. FDA Approvals
0 new drug approvals and 21 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Telemetry Monitor (iT30, iT50)510(k)Aug 6, 2026Cardiovascular |
| SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)510(k)Jul 2, 2026Cardiovascular |
| Holter ECG and ABP system (HolterABP)510(k)Feb 9, 2026Cardiovascular |
| Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)510(k)Dec 23, 2025Radiology |
| Fetal & Maternal Monitor (F15A, F15A Air)510(k)Aug 27, 2025Obstetrics/Gynecology |
| Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)510(k)Jul 29, 2025Cardiovascular |
| 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)510(k)Feb 20, 2025Radiology |
| Patient Monitor (RespArray)510(k)Jun 28, 2024Cardiovascular |
| Stimulation System (PA series, PR series, S series and Q series)510(k)May 16, 2024Physical Medicine |
| Patient Monitor (iX10, iX12, iX15)510(k)Apr 19, 2024Cardiovascular |
| Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s510(k)Mar 8, 2024Cardiovascular |
| Central Monitoring System (MFM-CMS)510(k)Feb 5, 2024Cardiovascular |
| Holter ECG and ABP System510(k)Sep 25, 2023Cardiovascular |
| Electrocardiograph: SE-1200 Pro and SE-1201 Pro510(k)Jul 28, 2023Cardiovascular |
| Patient Monitor: RespArray510(k)Aug 11, 2022Cardiovascular |
| Electrocardiograph510(k)Apr 7, 2022Cardiovascular |
| electrocardiograph: SE-1202510(k)Oct 1, 2021Cardiovascular |
| Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09510(k)Oct 1, 2021Cardiovascular |
| Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s510(k)Jan 28, 2021Cardiovascular |
| 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 LX28510(k)Jan 25, 2021Radiology |
| Patient Monitor510(k)Jan 23, 2021Cardiovascular |