510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
316
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
522
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
169
Obstetrics & Gynecology
62
Ophthalmic
50
Orthopedic
1295
Pathology
18
Physical Medicine
87
Radiology
871
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
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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Arkray, Inc.
Medical Device Manufacturer
·
US , Beverly , MA
Arkray, Inc. - FDA 510(k) Cleared Devices
18 submissions
·
18 cleared
·
Since 2002
18
Total
18
Cleared
0
Denied
FDA 510(k) cleared devices by Arkray, Inc.
Immunology
✕
1
devices
1-1 of 1
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Cleared
May 03, 2024
AUTION EYE AI-4510 Urine Particle Analysis System
K232416
·
LKM
Immunology
·
266d
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18
Chemistry
16
General & Plastic Surgery
1
Immunology
1