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181
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1604
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113
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80
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402
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2261
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1819
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266
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255
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236
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225
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225
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222
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Orthopedic Stereotaxic Instrument
186
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Abutment, Implant, Dental,...
171
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Thoracolumbosacral Pedicle Screw...
154
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Intervertebral Fusion Device...
149
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Ardent Sound, Inc.
Medical Device Manufacturer
·
US , Mesa , AZ
Ardent Sound, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2005
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ardent Sound, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 09, 2009
VOYAGER COMPACT IMAGING SYSTEM
K092182
·
IYO
Radiology
·
80d
Cleared
Apr 07, 2006
SEEKER/SPARK ULTRASOUND SYSTEM
K060800
·
IYO
Radiology
·
14d
Cleared
Mar 22, 2005
VOYAGER PERSONAL IMAGING DEVICE
K050551
·
IYO
Radiology
·
19d
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3
Radiology
3