510k
Database
Specialties
Anesthesiology
133
Cardiovascular
569
Chemistry
164
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
288
General & Plastic Surgery
515
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
167
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1292
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
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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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) cleared devices by 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