510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
318
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
524
General Hospital
375
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
234
Neurology
172
Obstetrics & Gynecology
62
Ophthalmic
51
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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Tissium SA
Medical Device Manufacturer
·
FR , Paris
Tissium SA - FDA 510(k) Cleared Devices
2 submissions
·
1 cleared
·
Since 2025
2
Total
1
Cleared
1
Denied
FDA 510(k) cleared devices by Tissium SA
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 08, 2025
Coaptium Connect with Tissium Light
K251957
·
SFD
Neurology
·
75d
Not Cleared
Jun 17, 2025
COAPTIUM Connect with TISSIUM LIGHT
DEN240066
·
SFD
Neurology
·
208d
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2
Neurology
2