510k
Database
Specialties
Anesthesiology
204
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735
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187
Dental
462
Ear, Nose, Throat
91
Gastroenterology & Urology
391
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767
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473
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77
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63
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1
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274
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296
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114
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76
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1474
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26
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152
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1083
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
130
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Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
QIH
Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Ebi, Inc.
Medical Device Manufacturer
·
US , Deer Field , IL
Ebi, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2008
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Ebi, Inc.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 22, 2020
Internal Hex Implant System
K190837
·
DZE
Dental
·
296d
Cleared
Aug 31, 2017
Internal Octa Implant System
K170031
·
DZE
Dental
·
239d
Cleared
Mar 27, 2015
EBI External Implant System
K142426
·
DZE
Dental
·
210d
Cleared
Feb 28, 2008
EBI INTERNAL IMPLANT SYSTEM
K073116
·
DZE
Dental
·
115d
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4
Dental
4