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1247
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309
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950
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181
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1604
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991
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113
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80
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402
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303
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2261
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1819
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138
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266
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255
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236
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225
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System, Imaging, Pulsed Doppler,...
225
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Plate, Fixation, Bone
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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Nordicimaginglab AS
Medical Device Manufacturer
·
NO , Bergen, Hordaland
Nordicimaginglab AS - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2008
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nordicimaginglab AS
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 25, 2009
NORDICBRAINEX SOFTWARE, VERSION 1.0
K092102
·
LLZ
Radiology
·
42d
Cleared
Jun 08, 2009
MODIFICATION TO NORDICICE SOFTWARE
K090546
·
LLZ
Radiology
·
98d
Cleared
Nov 21, 2008
NORDICICE SOFTWARE
K082441
·
LLZ
Radiology
·
88d
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3
Radiology
3