510k
Database
Specialties
Anesthesiology
3443
Cardiovascular
9751
Chemistry
8476
Dental
5893
Ear, Nose, Throat
1949
Gastroenterology & Urology
5112
General & Plastic Surgery
8049
General Hospital
6578
Hematology
1964
Immunology
2501
Medical Genetics
16
Microbiology
4740
Neurology
2849
Obstetrics & Gynecology
1842
Ophthalmic
1436
Orthopedic
12302
Pathology
622
Physical Medicine
1556
Radiology
8191
Toxicology
2128
Categories
GEX
Powered Laser Surgical Instrument
1289
GEI
Electrosurgical, Cutting &...
1165
LLZ
System, Image Processing,...
1128
HRS
Plate, Fixation, Bone
923
LNH
System, Nuclear Magnetic...
818
IYN
System, Imaging, Pulsed Doppler,...
793
JWH
Prosthesis, Knee,...
787
ESD
Hearing Aid, Air-conduction,...
740
GCJ
Laparoscope, General & Plastic...
702
DZE
Implant, Endosseous, Root-form
673
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Sigma
Medical Device Manufacturer
·
US , MD
Sigma - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1983
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