510k
Database
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Anesthesiology
694
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2137
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469
Dental
1725
Ear, Nose, Throat
309
Gastroenterology & Urology
1221
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2677
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2411
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153
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135
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13
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578
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1208
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554
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366
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3788
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57
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575
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3009
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172
Categories
LLZ
System, Image Processing,...
502
LZA
Polymer Patient Examination Glove
452
GEX
Powered Laser Surgical Instrument
437
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Electrosurgical, Cutting &...
393
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Mask, Surgical
387
IYN
System, Imaging, Pulsed Doppler,...
360
HRS
Plate, Fixation, Bone
350
MAX
Intervertebral Fusion Device...
308
OLO
Orthopedic Stereotaxic Instrument
286
QIH
Automated Radiological Image...
285
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Manufacturers
KR
Genoss
Medical Device Manufacturer
·
KR , Suwon-Si
Genoss - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2015
Official Website
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Genoss
Dental
✕
5
devices
1-5 of 5
Filters
Cleared
Apr 15, 2016
Rainbow Paste Stain
K151731
·
EIH
Dental
·
294d
Cleared
Jan 14, 2016
Rainbow Shine
K151842
·
EIH
Dental
·
191d
Cleared
Jan 14, 2016
Rainbow LS Pressing
K151846
·
EIH
Dental
·
191d
Cleared
Oct 28, 2015
Rainbow Trans
K151723
·
EIH
Dental
·
124d
Cleared
Oct 16, 2015
Rainbow Shade
K151844
·
EIH
Dental
·
101d
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Dental
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