510k
Database
Specialties
Anesthesiology
4111
Cardiovascular
10616
Chemistry
9372
Dental
6719
Ear, Nose, Throat
2124
Gastroenterology & Urology
5626
General & Plastic Surgery
9139
General Hospital
7416
Hematology
2116
Immunology
2750
Medical Genetics
18
Microbiology
5215
Neurology
3191
Obstetrics & Gynecology
2049
Ophthalmic
1581
Orthopedic
13311
Pathology
694
Physical Medicine
1758
Radiology
8901
Toxicology
2288
Categories
GEX
Powered Laser Surgical Instrument
1545
GEI
Electrosurgical, Cutting &...
1267
LLZ
System, Image Processing,...
1204
HRS
Plate, Fixation, Bone
1016
IYN
System, Imaging, Pulsed Doppler,...
892
LNH
System, Nuclear Magnetic...
841
JWH
Prosthesis, Knee,...
814
ESD
Hearing Aid, Air-conduction,...
812
GCJ
Laparoscope, General & Plastic...
803
DZE
Implant, Endosseous, Root-form
767
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
TR
Smart Alfa Teknoloji San. Ve Tic. A.S.
Medical Device Manufacturer
·
TR , Ankara
Smart Alfa Teknoloji San. Ve Tic. A.S. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
Recent clearances:
MSK Go
,
Nerveblox
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smart Alfa Teknoloji San. Ve Tic. A.S.
Anesthesiology
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 15, 2025
Nerveblox
K250818
·
QRG
Anesthesiology
·
150d
Filters
Filter by Specialty
All
2
Anesthesiology
1
Radiology
1