510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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About
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Disior, Ltd.
Medical Device Manufacturer
·
US , Helsinki Uusimaa , FL
Disior, Ltd. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2021
6
Total
6
Cleared
0
Denied
FDA 510(k) cleared devices by Disior, Ltd.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Sep 29, 2025
SMART PCFD
K250023
·
QIH
Radiology
·
269d
Cleared
Jul 02, 2024
SMART Bun-Yo-Matic X-Ray
K240736
·
QIH
Radiology
·
106d
Cleared
Jun 20, 2024
SMART Bun-Yo-Matic CT
K240642
·
QIH
Radiology
·
106d
Cleared
Dec 08, 2023
Bonelogic
K223757
·
QIH
Radiology
·
358d
Cleared
Feb 05, 2021
Bonelogic
K203290
·
LLZ
Radiology
·
88d
Filters
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6
Radiology
5
Orthopedic
1