Medical Device Manufacturer · CN , Shenzhen

Edan Instruments, Inc. - FDA 510(k) Cleared Devices

92 submissions · 92 cleared · Since 2004
92
Total
92
Cleared
0
Denied
92 devices
76-92 of 92
Cleared Nov 10, 2010
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K100797 · HGM
Obstetrics & Gynecology · 233d
Cleared Oct 28, 2010
ULTRASONIC TABLETOP DOPPLER
K102138 · MAA
Radiology · 90d
Cleared Aug 10, 2010
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
K101960 · HEP
Radiology · 29d
Cleared Apr 01, 2010
SE-601 SERIES ELECTROCARDIOGRAPH
K093869 · DPS
Cardiovascular · 105d
Cleared Dec 03, 2009
H100B PULSE OXIMETER
K092727 · DQA
Anesthesiology · 90d
Cleared Nov 10, 2009
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997 · KNG
Radiology · 43d
Cleared Oct 22, 2009
PC ECG, MODEL SE-1010
K092010 · DPS
Cardiovascular · 108d
Cleared Jul 24, 2009
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6,...
K091513 · DPS
Cardiovascular · 63d
Cleared Jun 19, 2009
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K091680 · ITX
Radiology · 9d
Cleared Jun 03, 2009
SE-601 SERIES ELECTROCARDIOGRAPH
K090367 · DPS
Cardiovascular · 110d
Cleared May 14, 2009
VITAL SIGNS MONITOR
K083821 · DQA
Anesthesiology · 143d
Cleared Nov 26, 2008
FETAL & MATERNAL MONITOR, MODEL F6, F9
K082602 · HGM
Obstetrics & Gynecology · 79d
Cleared Nov 07, 2008
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K082369 · HGM
Obstetrics & Gynecology · 81d
Cleared Mar 11, 2008
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC,...
K080087 · KNG
Radiology · 60d
Cleared Dec 28, 2007
CADENCE II
K073221 · HGM
Radiology · 43d
Cleared Sep 02, 2004
CADENCE, MODELS 2001 AND 2002
K040903 · HGM
Obstetrics & Gynecology · 148d
Cleared May 25, 2004
SONOTRAX ULTRASONIC POCKET DOPPLER
K040480 · KNG
Obstetrics & Gynecology · 90d

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