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."
25–48 of 94
Search insights Median review: 119d Cleared: 100% Top manufacturer: Edan Instruments, Inc. Lead specialty: Cardiovascular
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
Cleared Aug 30, 2018
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express
K173042 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 336d
Cleared Jun 06, 2018
SD1 Ultrasonic Pocket Doppler
K172780 · KNG
Edan Instruments, Inc.
Obstetrics & Gynecology · 265d
Cleared May 24, 2018
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound...
K180862 · IYN
Edan Instruments, Inc.
Radiology · 52d
Cleared Apr 13, 2018
U60 Diagnostic Ultrasound System
K180408 · IYN
Edan Instruments, Inc.
Radiology · 58d
Cleared Jan 24, 2018
Electrocardiograph
K171942 · DPS
Edan Instruments, Inc.
Cardiovascular · 210d
Cleared Nov 15, 2017
U50 Diagnostic Ultrasound System
K173003 · IYN
Edan Instruments, Inc.
Radiology · 49d
Cleared Sep 29, 2017
U2 Diagnostic Ultrasound System
K172380 · IYN
Edan Instruments, Inc.
Radiology · 53d
Cleared Sep 25, 2017
Electrocardiograph
K171943 · DPS
Edan Instruments, Inc.
Cardiovascular · 89d
Cleared Sep 06, 2017
Central Monitoring System
K171178 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 138d
Cleared Aug 18, 2017
Acclarix AX4 Diagnostic Ultrasound System
K171900 · IYN
Edan Instruments, Inc.
Radiology · 53d
Cleared Jul 18, 2017
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound...
K171824 · IYO
Edan Instruments, Inc.
Radiology · 29d
Cleared Jun 02, 2017
Electrocardiograph
K170995 · DPS
Edan Instruments, Inc.
Cardiovascular · 60d
Cleared Feb 15, 2017
PC ECG
K160876 · DPS
Edan Instruments, Inc.
Cardiovascular · 322d
Cleared Feb 03, 2017
Telemetry Transmitter
K161056 · MHX
Edan Instruments, Inc.
Cardiovascular · 295d
Cleared Jan 31, 2017
Acclarix LX8 Diagnostic Ultrasound System
K162055 · IYN
Edan Instruments, Inc.
Radiology · 190d
Cleared Dec 22, 2016
Patient Monitor
K160981 · MHX
Edan Instruments, Inc.
Cardiovascular · 259d
Cleared Jul 15, 2016
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid...
K151978 · CHL
Edan Instruments, Inc.
Chemistry · 364d
Cleared Jul 01, 2016
PC ECG
K161302 · DPS
Edan Instruments, Inc.
Cardiovascular · 53d
Cleared May 31, 2016
Acclarix AX8 Diagnostic Ultrasound System
K161300 · IYO
Edan Instruments, Inc.
Radiology · 22d
Cleared Apr 29, 2016
Patient Monitor
K152552 · MHX
Edan Instruments, Inc.
Cardiovascular · 234d
Cleared Apr 04, 2016
Acclarix LX8 Diagnostic Ultrasound System
K160790 · IYN
Edan Instruments, Inc.
Radiology · 13d
Cleared Feb 05, 2016
PC ECG
K152427 · DPS
Edan Instruments, Inc.
Cardiovascular · 163d