510k
Database
Specialties
Anesthesiology
140
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577
Chemistry
167
Dental
324
Ear, Nose, Throat
68
Gastroenterology & Urology
294
General & Plastic Surgery
534
General Hospital
382
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
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173
Obstetrics & Gynecology
67
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52
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1301
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18
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88
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886
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
135
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
LNH
System, Nuclear Magnetic...
83
JAK
System, X-ray, Tomography, Computed
79
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Medexel Co.,Ltd
Medical Device Manufacturer
·
KR , Anseong-Si
Medexel Co.,Ltd - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Medexel Co.,Ltd
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 15, 2024
TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
K231856
·
QNQ
General Hospital
·
266d
Cleared
Jul 24, 2018
Autokeeper
K172095
·
FMI
General Hospital
·
378d
Cleared
Feb 02, 2016
Top Fine Pen Needle
K152410
·
FMI
General Hospital
·
160d
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3
General Hospital
3