510k
Database
Specialties
Anesthesiology
144
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584
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167
Dental
327
Ear, Nose, Throat
68
Gastroenterology & Urology
297
General & Plastic Surgery
543
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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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175
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70
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53
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1308
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19
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90
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890
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
138
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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Zelegent, Inc.
Medical Device Manufacturer
·
US , Irvine , CA
Zelegent, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Zelegent, Inc.
Dental
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 27, 2022
Elevo Snoring Intervention Set
K213475
·
LRK
Dental
·
90d
Filters
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2
Ear, Nose, Throat
1
Dental
1