510k
Database
Specialties
Anesthesiology
133
Cardiovascular
568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
371
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
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163
Obstetrics & Gynecology
61
Ophthalmic
49
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1291
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18
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85
Radiology
866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Athelas, Inc.
Medical Device Manufacturer
·
US , Mountain View , CA
Athelas, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Athelas, Inc.
Hematology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 06, 2026
Athelas Home
K243348
·
GKZ
Hematology
·
466d
Cleared
Mar 22, 2022
Athelas Home
K200828
·
GKZ
Hematology
·
722d
Cleared
Nov 05, 2018
Athelas One
K181288
·
GKZ
Hematology
·
173d
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3
Hematology
3