510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
933
General & Plastic Surgery
2140
General Hospital
1991
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
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942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2743
Pathology
52
Physical Medicine
515
Radiology
2354
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
266
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Hyundae Meditech Co., Ltd.
Medical Device Manufacturer
·
KR , Wonju-Si
Hyundae Meditech Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hyundae Meditech Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 27, 2024
Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150...
K242571
·
NEW
General & Plastic Surgery
·
29d
Cleared
Mar 27, 2024
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )
K240389
·
NEW
General & Plastic Surgery
·
48d
Filters
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2
General & Plastic Surgery
2