510k
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392
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1204
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298
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901
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169
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713
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1538
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111
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79
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288
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177
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2201
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360
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1767
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137
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GEX
Powered Laser Surgical Instrument
253
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System, Image Processing,...
233
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Automated Radiological Image...
232
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221
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Electrosurgical, Cutting &...
218
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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...
150
MAX
Intervertebral Fusion Device...
146
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Surgiceye GmbH
Medical Device Manufacturer
·
DE , Munich, Bavaria
Surgiceye GmbH - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2011
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Surgiceye GmbH
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 11, 2014
DECLIPSESPECT LAPAROSCOPY
K133781
·
IZD
Radiology
·
120d
Cleared
Jan 25, 2013
DECLIPSESPECT VIEWER
K123917
·
IZD
Radiology
·
37d
Cleared
Mar 22, 2011
CONFIDENT SURGERY SUITE 300, MODEL CSS300
K101887
·
IZD
Radiology
·
259d
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3
Radiology
3