510k
Database
Specialties
Anesthesiology
511
Cardiovascular
1587
Chemistry
356
Dental
1281
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2112
General Hospital
1885
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
931
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422
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267
Orthopedic
2683
Pathology
50
Physical Medicine
507
Radiology
2295
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
392
LLZ
System, Image Processing,...
358
GEX
Powered Laser Surgical Instrument
348
GEI
Electrosurgical, Cutting &...
292
FXX
Mask, Surgical
284
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Incore Co., Ltd.
Medical Device Manufacturer
·
KR , Daegu
Incore Co., Ltd. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2022
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Incore Co., Ltd.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 19, 2024
Hemoblock_S (Prescription)
K232216
·
QSY
General & Plastic Surgery
·
268d
Cleared
Sep 28, 2022
CORE-SPORT
K220081
·
OTJ
General & Plastic Surgery
·
261d
Cleared
Jun 21, 2022
CORE-Trocar
K211148
·
GCJ
General & Plastic Surgery
·
428d
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6
Gastroenterology & Urology
3
General & Plastic Surgery
3