Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

92 results for "Edan Instruments, Inc."
1–24 of 92
Cleared Feb 09, 2026
Holter ECG and ABP system (HolterABP)
K251591 · DQK
Edan Instruments, Inc.
Cardiovascular · 262d
Cleared Dec 23, 2025
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
K251268 · IYN
Edan Instruments, Inc.
Radiology · 243d
Cleared Aug 27, 2025
Fetal & Maternal Monitor (F15A, F15A Air)
K241882 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 425d
Cleared Jul 29, 2025
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
K250179 · MHX
Edan Instruments, Inc.
Cardiovascular · 188d
Cleared Feb 20, 2025
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7,...
K250214 · IYN
Edan Instruments, Inc.
Radiology · 27d
Cleared Jun 28, 2024
Patient Monitor (RespArray)
K240320 · MHX
Edan Instruments, Inc.
Cardiovascular · 147d
Cleared May 16, 2024
Stimulation System (PA series, PR series, S series and Q series)
K232786 · IPF
Edan Instruments, Inc.
Physical Medicine · 248d
Cleared Apr 19, 2024
Patient Monitor (iX10, iX12, iX15)
K232962 · MHX
Edan Instruments, Inc.
Cardiovascular · 211d
Cleared Mar 08, 2024
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
K233038 · MWI
Edan Instruments, Inc.
Cardiovascular · 165d
Cleared Feb 05, 2024
Central Monitoring System (MFM-CMS)
K232694 · MHX
Edan Instruments, Inc.
Cardiovascular · 153d
Cleared Sep 25, 2023
Holter ECG and ABP System
K230184 · DSH
Edan Instruments, Inc.
Cardiovascular · 245d
Cleared Jul 28, 2023
Electrocardiograph: SE-1200 Pro and SE-1201 Pro
K222902 · DPS
Edan Instruments, Inc.
Cardiovascular · 308d
Cleared Aug 11, 2022
Patient Monitor: RespArray
K220308 · MHX
Edan Instruments, Inc.
Cardiovascular · 190d
Cleared Apr 07, 2022
Electrocardiograph
K212278 · DPS
Edan Instruments, Inc.
Cardiovascular · 261d
Cleared Oct 01, 2021
electrocardiograph: SE-1202
K210140 · DPS
Edan Instruments, Inc.
Cardiovascular · 255d
Cleared Oct 01, 2021
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
K210139 · DXN
Edan Instruments, Inc.
Cardiovascular · 255d
Cleared Jan 28, 2021
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
K202892 · MWI
Edan Instruments, Inc.
Cardiovascular · 122d
Cleared Jan 25, 2021
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp,...
K202856 · IYN
Edan Instruments, Inc.
Radiology · 119d
Cleared Jan 23, 2021
Patient Monitor
K202336 · MHX
Edan Instruments, Inc.
Cardiovascular · 159d
Cleared May 21, 2020
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic...
K192879 · IYN
Edan Instruments, Inc.
Radiology · 234d
Cleared Apr 02, 2020
Patient Monitor
K192514 · MHX
Edan Instruments, Inc.
Cardiovascular · 203d
Cleared Nov 27, 2019
Diagnostic Ultrasound System
K192791 · IYO
Edan Instruments, Inc.
Radiology · 58d
Cleared Mar 28, 2019
Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic...
K190186 · IYO
Edan Instruments, Inc.
Radiology · 55d
Cleared Dec 21, 2018
vital signs monitor
K180380 · DQA
Edan Instruments, Inc.
Cardiovascular · 312d