510k
Database
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Anesthesiology
550
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1722
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385
Dental
1381
Ear, Nose, Throat
254
Gastroenterology & Urology
986
General & Plastic Surgery
2225
General Hospital
2091
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127
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103
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8
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474
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985
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443
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283
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3055
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52
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515
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2501
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155
Categories
LZA
Polymer Patient Examination Glove
417
LLZ
System, Image Processing,...
401
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Powered Laser Surgical Instrument
363
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Mask, Surgical
359
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Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
298
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Sewonmedix, Inc.
Medical Device Manufacturer
·
KR , Busan
Sewonmedix, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2016
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sewonmedix, Inc.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 07, 2023
IH Implant System
K222707
·
DZE
Dental
·
303d
Cleared
Oct 14, 2016
IH Implant System
K153521
·
DZE
Dental
·
311d
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Dental
2