510k
Database
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405
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1224
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304
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924
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175
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719
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1569
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945
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112
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79
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4
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398
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682
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292
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183
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2212
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42
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363
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1797
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138
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Powered Laser Surgical Instrument
258
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System, Image Processing,...
248
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Automated Radiological Image...
236
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System, Imaging, Pulsed Doppler,...
222
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Electrosurgical, Cutting &...
219
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Plate, Fixation, Bone
217
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Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
146
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Giotto USA, LLC
Medical Device Manufacturer
·
US , Carmel , IN
Giotto USA, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2006
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Giotto USA, LLC
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 10, 2012
BIOPSY DIGIT S BIOPSY SL
K113607
·
IZH
Radiology
·
248d
Cleared
Oct 27, 2011
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
K111434
·
MUE
Radiology
·
157d
Cleared
Sep 11, 2006
BIOPSY DIGIT-AM
K062039
·
IZH
Radiology
·
54d
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3
Radiology
3