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510k Database
Manufacturers
US
Edlen Imaging, LLC
Medical Device Manufacturer
·
US , Phoenix , AZ
Edlen Imaging, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2011
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Edlen Imaging, LLC
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 07, 2016
X-VIEW, IMAGEN
K151137
·
OAS
Radiology
·
405d
Cleared
Aug 26, 2015
EDLENi Intra-Oral Sensor
K150823
·
MUH
Radiology
·
152d
Cleared
Sep 19, 2011
EDLEN IMAGING - GEMINI DUSB
K103290
·
MUH
Radiology
·
315d
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3
Radiology
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