510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1672
Chemistry
362
Dental
1335
Ear, Nose, Throat
245
Gastroenterology & Urology
964
General & Plastic Surgery
2190
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2900
Pathology
52
Physical Medicine
515
Radiology
2433
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Simda Co., Ltd.
Medical Device Manufacturer
·
KR , Busan
Simda Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Simda Co., Ltd.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 18, 2025
SIMDA Abutments
K252320
·
NHA
Dental
·
146d
Cleared
Oct 26, 2023
SIMDA abutment
K232271
·
NHA
Dental
·
87d
Cleared
May 24, 2023
SIMDA Abutment
K223663
·
NHA
Dental
·
168d
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3
Dental
3