510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
317
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
522
General Hospital
373
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
233
Neurology
171
Obstetrics & Gynecology
62
Ophthalmic
50
Orthopedic
1295
Pathology
18
Physical Medicine
87
Radiology
871
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Tuned , Ltd.
Medical Device Manufacturer
·
IL , Gan Yoshiya
Tuned , Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Tuned , Ltd.
Ear, Nose, Throat
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 26, 2025
Tuned Self-Fitting Mobile App
K251208
·
SCR
Ear, Nose, Throat
·
161d
Cleared
Sep 08, 2023
Intrisound™ Tuned Lumen® 155 Hearing Aids
K223848
·
QUH
Ear, Nose, Throat
·
260d
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Ear, Nose, Throat
2