510k
Database
Specialties
Anesthesiology
133
Cardiovascular
569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
288
General & Plastic Surgery
516
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
167
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1292
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
Browse all 339 categories →
Search
Reports
About
Home
Sigma Biomedical
Medical Device Manufacturer
·
US , Sunrise , FL
Sigma Biomedical - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Sigma Biomedical
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 07, 2025
Triathlon Pro
K243131
·
NUH
Neurology
·
403d
Filters
Filter by Specialty
All
1
Neurology
1