510k
Database
Specialties
Anesthesiology
130
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565
Chemistry
162
Dental
309
Ear, Nose, Throat
68
Gastroenterology & Urology
286
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511
General Hospital
369
Hematology
67
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56
Medical Genetics
0
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232
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163
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60
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49
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1285
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
82
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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Koios Medical, Inc.
Medical Device Manufacturer
·
US , New York , NY
Koios Medical, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Koios Medical, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 15, 2024
Koios DS
K242130
·
POK
Radiology
·
116d
Cleared
Dec 16, 2021
Koios DS
K212616
·
POK
Radiology
·
120d
Cleared
Jul 03, 2019
Koios DS for Breast
K190442
·
POK
Radiology
·
128d
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3
Radiology
3