510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1663
Chemistry
362
Dental
1334
Ear, Nose, Throat
244
Gastroenterology & Urology
963
General & Plastic Surgery
2184
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
963
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2875
Pathology
52
Physical Medicine
515
Radiology
2430
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Saeyang Microtech Co., Ltd.
Medical Device Manufacturer
·
US , Great Neck , NY
Saeyang Microtech Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2013
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Saeyang Microtech Co., Ltd.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 19, 2022
Pro M Class
K213897
·
EKX
Dental
·
279d
Cleared
Apr 24, 2015
KI-20
K141482
·
EBW
Dental
·
324d
Cleared
Aug 16, 2013
ENDO A CLASS
K123582
·
EKX
Dental
·
269d
Cleared
Aug 16, 2013
ENDO E CLASS
K123608
·
EBW
Dental
·
268d
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4
Dental
4