510k
Database
Specialties
Anesthesiology
198
Cardiovascular
720
Chemistry
185
Dental
450
Ear, Nose, Throat
86
Gastroenterology & Urology
382
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750
General Hospital
460
Hematology
74
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61
Medical Genetics
1
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271
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287
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111
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75
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1464
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26
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145
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1067
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
161
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
LLZ
System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
106
GEI
Electrosurgical, Cutting &...
103
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Koncept Innovators, LLC
Medical Device Manufacturer
·
US , Myrtle Beach , SC
Koncept Innovators, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Koncept Innovators, LLC
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 23, 2020
Somnos Anti-Snoring Mouth Guard
K201484
·
LRK
Dental
·
172d
Cleared
Jan 18, 2019
Bright Guard
K181099
·
OBR
Dental
·
267d
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2
Dental
2