510k
Database
Specialties
Anesthesiology
532
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1643
Chemistry
359
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1318
Ear, Nose, Throat
242
Gastroenterology & Urology
955
General & Plastic Surgery
2169
General Hospital
2036
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126
Immunology
97
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8
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462
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952
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Jeesung Medical Co., Ltd.
Medical Device Manufacturer
·
KR , Daejeon
Jeesung Medical Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jeesung Medical Co., Ltd.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 18, 2022
Jeesung Safety Syringe and Single Use Needles
K212518
·
MEG
General Hospital
·
373d
Cleared
Jul 11, 2016
JSM Insulin Pen Needle
K152166
·
FMI
General Hospital
·
342d
Cleared
Jun 28, 2016
Jeesung Safety Syringe and Single Use Needles
K152606
·
MEG
General Hospital
·
291d
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3
General Hospital
3