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236
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223
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220
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217
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Orthopedic Stereotaxic Instrument
183
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
151
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Intervertebral Fusion Device...
146
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Candelis, Inc.
Medical Device Manufacturer
·
US , Denton , TX
Candelis, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2008
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Candelis, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 15, 2011
ASTRA
K111694
·
LLZ
Radiology
·
91d
Cleared
Oct 08, 2009
IMAGEGRID RADIOLOGY VIEWER SYSTEM
K092949
·
LLZ
Radiology
·
14d
Cleared
Feb 22, 2008
IMAGEGRID
K080333
·
LLZ
Radiology
·
15d
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3
Radiology
3