510k
Database
Specialties
Anesthesiology
142
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583
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167
Dental
326
Ear, Nose, Throat
68
Gastroenterology & Urology
297
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540
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387
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67
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58
Medical Genetics
0
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236
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174
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70
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53
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1305
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18
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89
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889
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
136
OLO
Orthopedic Stereotaxic Instrument
118
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
84
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Ulab Systems, Inc.
Medical Device Manufacturer
·
US , Menlo Park , CA
Ulab Systems, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2018
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Ulab Systems, Inc.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 24, 2022
uLab Systems Dental Aligner Kit
K211510
·
NXC
Dental
·
286d
Cleared
Jun 23, 2020
ULab Systems uDesign Software
K200772
·
PNN
Dental
·
90d
Cleared
Feb 11, 2020
ULab Systems Dental Aligner Kit
K192596
·
NXC
Dental
·
144d
Cleared
Jan 09, 2018
ULab Systems Treatment Planning Software
K171295
·
PNN
Dental
·
252d
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4
Dental
4