Edan Instruments, Inc. - FDA 510(k) Cleared Devices
92
Total
92
Cleared
0
Denied
92 devices
Cleared
Nov 10, 2010
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
Obstetrics & Gynecology
233d
Cleared
Oct 28, 2010
ULTRASONIC TABLETOP DOPPLER
Radiology
90d
Cleared
Aug 10, 2010
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
Radiology
29d
Cleared
Apr 01, 2010
SE-601 SERIES ELECTROCARDIOGRAPH
Cardiovascular
105d
Cleared
Dec 03, 2009
H100B PULSE OXIMETER
Anesthesiology
90d
Cleared
Nov 10, 2009
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
Radiology
43d
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 19, 2009
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Radiology
9d
Cleared
Jun 03, 2009
SE-601 SERIES ELECTROCARDIOGRAPH
Cardiovascular
110d
Cleared
May 14, 2009
VITAL SIGNS MONITOR
Anesthesiology
143d
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
Mar 11, 2008
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC,...
Radiology
60d
Cleared
Dec 28, 2007
CADENCE II
Radiology
43d
Cleared
Sep 02, 2004
CADENCE, MODELS 2001 AND 2002
Obstetrics & Gynecology
148d
Cleared
May 25, 2004
SONOTRAX ULTRASONIC POCKET DOPPLER
Obstetrics & Gynecology
90d
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