510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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About
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Azena Medical, LLC
Medical Device Manufacturer
·
US , Walnut Creek , CA
Azena Medical, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2015
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Azena Medical, LLC
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 10, 2026
Gemini NOVA 810+980 Soft Tissue Laser
K260765
·
NVK
Dental
·
1d
Cleared
Nov 18, 2021
Gemini 2 810+980 Soft Tissue Laser
K210350
·
NVK
Dental
·
283d
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4
General & Plastic Surgery
2
Dental
2