510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1614
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
937
General & Plastic Surgery
2142
General Hospital
2013
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
458
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2757
Pathology
52
Physical Medicine
515
Radiology
2354
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Inion OY
Medical Device Manufacturer
·
FI , Tampere
Inion OY - FDA 510(k) Cleared Devices
14 submissions
·
13 cleared
·
Since 2005
14
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Inion OY
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 07, 2025
Inion CPS 1.5 Baby Bioabsorbable Fixation System
K251441
·
JEY
Dental
·
182d
Cleared
Jan 29, 2013
INION CPS ORBITAL PLATES
K122890
·
JEY
Dental
·
131d
Cleared
Jul 24, 2007
INION BIORESTORE
K070784
·
LYC
Dental
·
125d
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14
Orthopedic
10
Dental
3
Neurology
1