510k
Database
Specialties
Anesthesiology
527
Cardiovascular
1633
Chemistry
356
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
946
General & Plastic Surgery
2157
General Hospital
2020
Hematology
126
Immunology
92
Medical Genetics
8
Microbiology
459
Neurology
948
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2780
Pathology
52
Physical Medicine
515
Radiology
2364
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
272
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Medical Device Manufacturer
·
BR , Sao Carlos
Braincare Desenvolvimento E Inovacao Tecnologica S.A. - FDA 510(k) Cl...
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 08, 2021
B4C System
K201989
·
GWM
Neurology
·
448d
Cleared
Oct 17, 2019
BcSs-PICNI-2000 Sensor
K182073
·
GWM
Neurology
·
442d
Filters
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2
Neurology
2