Edan Instruments, Inc. - FDA 510(k) Cleared Devices
92
Total
92
Cleared
0
Denied
FDA 510(k) cleared devices by Edan Instruments, Inc. Obstetrics & Gynecology ✕
15 devices
Cleared
Aug 27, 2025
Fetal & Maternal Monitor (F15A, F15A Air)
Obstetrics & Gynecology
425d
Cleared
Aug 30, 2018
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express
Obstetrics & Gynecology
336d
Cleared
Jun 06, 2018
SD1 Ultrasonic Pocket Doppler
Obstetrics & Gynecology
265d
Cleared
Sep 06, 2017
Central Monitoring System
Obstetrics & Gynecology
138d
Cleared
Dec 01, 2015
Video Colposcope
Obstetrics & Gynecology
145d
Cleared
Jul 01, 2015
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
Obstetrics & Gynecology
89d
Cleared
Mar 30, 2015
CENTRAL MONITORING SYSTEM
Obstetrics & Gynecology
96d
Cleared
Feb 06, 2015
ULTRASONIC POCKET DOPPLER
Obstetrics & Gynecology
337d
Cleared
Jan 13, 2011
FETAL MONITORS, MODELS F2 AND F3
Obstetrics & Gynecology
168d
Cleared
Jan 06, 2011
CENTRAL MONITORING SYSTEM
Obstetrics & Gynecology
328d
Cleared
Nov 10, 2010
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
Obstetrics & Gynecology
233d
Cleared
Nov 26, 2008
FETAL & MATERNAL MONITOR, MODEL F6, F9
Obstetrics & Gynecology
79d
Cleared
Nov 07, 2008
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
Obstetrics & Gynecology
81d
Cleared
Sep 02, 2004
CADENCE, MODELS 2001 AND 2002
Obstetrics & Gynecology
148d
Cleared
May 25, 2004
SONOTRAX ULTRASONIC POCKET DOPPLER
Obstetrics & Gynecology
90d