510k
Database
Specialties
Anesthesiology
132
Cardiovascular
568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
371
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1291
Pathology
18
Physical Medicine
85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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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) cleared devices by 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