Edan Instruments, Inc. - FDA 510(k) Cleared Devices
94
Total
94
Cleared
0
Denied
44 devices
Cleared
Apr 29, 2016
Patient Monitor
Cardiovascular
234d
Cleared
Feb 05, 2016
PC ECG
Cardiovascular
163d
Cleared
Jan 27, 2016
Holter System
Cardiovascular
210d
Cleared
Mar 20, 2014
IM60/IM70 PATIENT MONITOR
Cardiovascular
265d
Cleared
Feb 25, 2014
SE-601 SERIES ELECTROCARDIOGRAPH
Cardiovascular
277d
Cleared
Nov 22, 2013
PC ECG
Cardiovascular
155d
Cleared
Jun 21, 2013
MFM-CMS CENTRAL MONITORING SYSTEM
Cardiovascular
469d
Cleared
May 16, 2012
PATIENT MONITOR
Cardiovascular
117d
Cleared
Mar 16, 2012
ELECTROCARDIOGRAPH
Cardiovascular
53d
Cleared
Feb 14, 2012
VITAL SIGNS MONITOR
Cardiovascular
27d
Cleared
Feb 06, 2012
PATIENT MONITOR
Cardiovascular
56d
Cleared
Feb 01, 2012
PATIENT MONITOR
Cardiovascular
58d
Cleared
Jul 20, 2011
PATIENT MONITOR
Cardiovascular
110d
Cleared
Dec 03, 2010
PC ECG
Cardiovascular
65d
Cleared
Dec 02, 2010
ELECTROCARDIOGRAPH
Cardiovascular
64d
Cleared
Apr 01, 2010
SE-601 SERIES ELECTROCARDIOGRAPH
Cardiovascular
105d
Cleared
Oct 22, 2009
PC ECG, MODEL SE-1010
Cardiovascular
108d
Cleared
Jul 24, 2009
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6,...
Cardiovascular
63d
Cleared
Jun 03, 2009
SE-601 SERIES ELECTROCARDIOGRAPH
Cardiovascular
110d