510k
Database
Specialties
Anesthesiology
6665
Cardiovascular
15341
Chemistry
11460
Dental
10329
Ear, Nose, Throat
2867
Gastroenterology & Urology
8072
General & Plastic Surgery
14503
General Hospital
12738
Hematology
2701
Immunology
3194
Medical Genetics
20
Microbiology
6030
Neurology
5081
Obstetrics & Gynecology
3453
Ophthalmic
3170
Orthopedic
17031
Pathology
899
Physical Medicine
3274
Radiology
13226
Toxicology
2712
Categories
Powered Laser Surgical Instrument
GEX
2506
System, Image Processing, Radiological
LLZ
2123
Electrosurgical, Cutting &...
GEI
1999
Implant, Endosseous, Root-form
DZE
1365
Plate, Fixation, Bone
HRS
1298
Laparoscope, General & Plastic Surgery
GCJ
1165
System, Imaging, Pulsed Doppler,...
IYN
1152
Polymer Patient Examination Glove
LZA
1134
System, Nuclear Magnetic Resonance...
LNH
1020
Screw, Fixation, Bone
HWC
1011
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Smr
Share
Medical Device Manufacturer
·
US , Mchenry , IL
Smr - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1980
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smr
Ophthalmic
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 16, 1980
DIMENSION I REFRACTION SYSTEM
K801767
·
HLM
Ophthalmic
·
50d
Filters
Filter by Specialty
All
2
Ophthalmic
1
General Hospital
1