510k
Database
Specialties
Anesthesiology
6246
Cardiovascular
14514
Chemistry
11215
Dental
9689
Ear, Nose, Throat
2778
Gastroenterology & Urology
7598
General & Plastic Surgery
13605
General Hospital
11700
Hematology
2624
Immunology
3131
Medical Genetics
20
Microbiology
5934
Neurology
4744
Obstetrics & Gynecology
3175
Ophthalmic
2913
Orthopedic
16479
Pathology
880
Physical Medicine
2979
Radiology
12387
Toxicology
2630
Categories
GEX
Powered Laser Surgical Instrument
2340
LLZ
System, Image Processing,...
1953
GEI
Electrosurgical, Cutting &...
1847
DZE
Implant, Endosseous, Root-form
1264
HRS
Plate, Fixation, Bone
1254
IYN
System, Imaging, Pulsed Doppler,...
1108
GCJ
Laparoscope, General & Plastic...
1092
LZA
Polymer Patient Examination Glove
1042
LNH
System, Nuclear Magnetic...
979
HWC
Screw, Fixation, Bone
966
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Sigma
Share
Medical Device Manufacturer
·
US , MD
Sigma - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1983
Recent clearances:
SMART ADJUSTER (SA201)
Official Website
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sigma
Physical Medicine
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 10, 1997
SMART ADJUSTER (SA201)
K962239
·
LXM
Physical Medicine
·
213d
Filters
Filter by Specialty
All
6
General Hospital
3
Hematology
2
Physical Medicine
1