510k
Database
Specialties
Anesthesiology
142
Cardiovascular
581
Chemistry
167
Dental
326
Ear, Nose, Throat
68
Gastroenterology & Urology
297
General & Plastic Surgery
540
General Hospital
386
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
235
Neurology
174
Obstetrics & Gynecology
69
Ophthalmic
53
Orthopedic
1305
Pathology
18
Physical Medicine
89
Radiology
889
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
136
OLO
Orthopedic Stereotaxic Instrument
118
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
84
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Elute, Inc.
Medical Device Manufacturer
·
US , Salt Lake City , UT
Elute, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Elute, Inc.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 26, 2025
BonVie+
K250346
·
MQV
Orthopedic
·
20d
Cleared
Aug 06, 2018
EP Granules™ BVF
K180853
·
MQV
Orthopedic
·
126d
Filters
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2
Orthopedic
2