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."
49–72 of 94
Search insights Median review: 119d Cleared: 100% Top manufacturer: Edan Instruments, Inc. Lead specialty: Cardiovascular
Cleared Jan 29, 2016
SD5 & SD6 Ultrasonic Tabletop Doppler
K153475 · KNG
Edan Instruments, Inc.
Radiology · 58d
Cleared Jan 27, 2016
Holter System
K151787 · DQK
Edan Instruments, Inc.
Cardiovascular · 210d
Cleared Dec 01, 2015
Video Colposcope
K151878 · HEX
Edan Instruments, Inc.
Obstetrics & Gynecology · 145d
Cleared Jul 01, 2015
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
K150901 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 89d
Cleared May 06, 2015
Acclarix Diagnostic Ultrasound System
K150999 · IYO
Edan Instruments, Inc.
Radiology · 21d
Cleared Mar 30, 2015
CENTRAL MONITORING SYSTEM
K143695 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 96d
Cleared Feb 20, 2015
U50 Diagnostic Ultrasound System
K142511 · IYN
Edan Instruments, Inc.
Radiology · 165d
Cleared Feb 06, 2015
ULTRASONIC POCKET DOPPLER
K140579 · KNG
Edan Instruments, Inc.
Obstetrics & Gynecology · 337d
Cleared Mar 20, 2014
IM60/IM70 PATIENT MONITOR
K131971 · MHX
Edan Instruments, Inc.
Cardiovascular · 265d
Cleared Feb 25, 2014
SE-601 SERIES ELECTROCARDIOGRAPH
K131503 · DPS
Edan Instruments, Inc.
Cardiovascular · 277d
Cleared Nov 22, 2013
PC ECG
K131819 · DPS
Edan Instruments, Inc.
Cardiovascular · 155d
Cleared Sep 17, 2013
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K131830 · IYO
Edan Instruments, Inc.
Radiology · 89d
Cleared Aug 30, 2013
VITAL SIGNS MONITOR
K131818 · DQA
Edan Instruments, Inc.
Anesthesiology · 71d
Cleared Jun 21, 2013
MFM-CMS CENTRAL MONITORING SYSTEM
K120727 · MHX
Edan Instruments, Inc.
Cardiovascular · 469d
Cleared Feb 08, 2013
DIAGNOSTIC ULTRASOUND SYSTEM
K123249 · IYN
Edan Instruments, Inc.
Radiology · 114d
Cleared Oct 12, 2012
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6
K122574 · IYO
Edan Instruments, Inc.
Radiology · 50d
Cleared May 16, 2012
PATIENT MONITOR
K120173 · MHX
Edan Instruments, Inc.
Cardiovascular · 117d
Cleared Mar 16, 2012
ELECTROCARDIOGRAPH
K120188 · DPS
Edan Instruments, Inc.
Cardiovascular · 53d
Cleared Feb 14, 2012
VITAL SIGNS MONITOR
K120144 · DXN
Edan Instruments, Inc.
Cardiovascular · 27d
Cleared Feb 06, 2012
PATIENT MONITOR
K113653 · MHX
Edan Instruments, Inc.
Cardiovascular · 56d
Cleared Feb 01, 2012
PATIENT MONITOR
K113623 · MHX
Edan Instruments, Inc.
Cardiovascular · 58d
Cleared Jul 20, 2011
PATIENT MONITOR
K110922 · MHX
Edan Instruments, Inc.
Cardiovascular · 110d
Cleared Apr 26, 2011
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K110999 · ITX
Edan Instruments, Inc.
Radiology · 15d
Cleared Jan 13, 2011
FETAL MONITORS, MODELS F2 AND F3
K102140 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 168d