510k
Database
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395
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1206
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298
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901
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170
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713
General & Plastic Surgery
1540
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925
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112
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79
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394
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668
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290
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178
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2201
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42
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360
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1771
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137
Categories
GEX
Powered Laser Surgical Instrument
253
LLZ
System, Image Processing,...
234
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Automated Radiological Image...
232
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System, Imaging, Pulsed Doppler,...
221
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Electrosurgical, Cutting &...
218
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Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
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Nds Surgical Imaging
Medical Device Manufacturer
·
US , San Jose , CA
Nds Surgical Imaging - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2008
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nds Surgical Imaging
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 28, 2014
THE DOME S6C
K133609
·
LLZ
Radiology
·
95d
Cleared
Jan 30, 2014
DOME S10
K132770
·
LLZ
Radiology
·
148d
Cleared
Apr 06, 2012
THE DOME GX4MP COLOR NONITOR
K120709
·
LLZ
Radiology
·
29d
Cleared
Feb 21, 2008
PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
K080320
·
LLZ
Radiology
·
15d
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6
Radiology
4
General & Plastic Surgery
2