510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
316
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1295
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
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Braincool AB
Medical Device Manufacturer
·
SE , Medicon Village
Braincool AB - FDA 510(k) Cleared Devices
4 submissions
·
3 cleared
·
Since 2017
4
Total
3
Cleared
1
Denied
FDA 510(k) cleared devices by Braincool AB
Dental
✕
1
devices
1-1 of 1
Filters
Not Cleared
Oct 14, 2022
The Cooral System
DEN210027
·
QUA
Dental
·
469d
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4
Cardiovascular
3
Dental
1