510k
Database
Specialties
Anesthesiology
198
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722
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185
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450
Ear, Nose, Throat
86
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383
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751
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461
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74
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61
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1
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271
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288
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111
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75
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1464
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26
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146
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1069
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
162
HRS
Plate, Fixation, Bone
150
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Orthopedic Stereotaxic Instrument
128
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System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
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Automated Radiological Image...
107
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Imaging Biometrics, LLC
Medical Device Manufacturer
·
US , Elm Grove , WI
Imaging Biometrics, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2008
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Imaging Biometrics, LLC
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 29, 2020
LSN
K201092
·
JAK
Radiology
·
189d
Cleared
Sep 26, 2019
StoneChecker
K191530
·
LLZ
Radiology
·
108d
Cleared
Jan 11, 2013
IB CLINIC
K123302
·
LLZ
Radiology
·
80d
Cleared
May 15, 2008
IB NEURO, VERSION 1.0
K080762
·
LNH
Radiology
·
58d
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4
Radiology
4