Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

94 results for "Edan Instruments, Inc."
1–24 of 94
Search insights Median review: 119d Cleared: 100% Top manufacturer: Edan Instruments, Inc. Lead specialty: Cardiovascular
Cleared Aug 06, 2026
Telemetry Monitor (iT30, iT50)
K251508 · MHX
Edan Instruments, Inc.
Cardiovascular · 447d
Cleared Jul 02, 2026
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
K252463 · DPS
Edan Instruments, Inc.
Cardiovascular · 330d
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