510k
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385
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1196
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292
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889
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164
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703
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1514
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108
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78
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390
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659
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281
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173
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2189
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355
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1745
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137
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GEX
Powered Laser Surgical Instrument
252
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Automated Radiological Image...
230
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System, Image Processing,...
226
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System, Imaging, Pulsed Doppler,...
221
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Plate, Fixation, Bone
217
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Electrosurgical, Cutting &...
211
OLO
Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
148
MAX
Intervertebral Fusion Device...
146
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Gammex, Inc.
Medical Device Manufacturer
·
US , Middleton , WI
Gammex, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1995
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gammex, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 11, 2015
CT Sim Laser System
K152303
·
IWE
Radiology
·
28d
Cleared
Apr 22, 1996
PID-1 PRECISION INTELLIGENT DOSIMETER
K954564
·
IYE
Radiology
·
203d
Cleared
Oct 07, 1995
COURIER II
K953514
·
LMD
Radiology
·
73d
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3
Radiology
3