510k
Database
Specialties
Anesthesiology
374
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1179
Chemistry
288
Dental
874
Ear, Nose, Throat
161
Gastroenterology & Urology
689
General & Plastic Surgery
1478
General Hospital
870
Hematology
108
Immunology
77
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1
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385
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644
Obstetrics & Gynecology
269
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171
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2171
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41
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350
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1718
Toxicology
135
Categories
GEX
Powered Laser Surgical Instrument
250
QIH
Automated Radiological Image...
226
IYN
System, Imaging, Pulsed Doppler,...
221
LLZ
System, Image Processing,...
221
HRS
Plate, Fixation, Bone
216
GEI
Electrosurgical, Cutting &...
207
OLO
Orthopedic Stereotaxic Instrument
180
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
147
MAX
Intervertebral Fusion Device...
146
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Bontech, Inc.
Medical Device Manufacturer
·
KR , Suwon-Si
Bontech, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2016
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bontech, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 21, 2017
BSD4343R Digital Flat Panel X-ray Detector
K171485
·
MQB
Radiology
·
30d
Cleared
Oct 14, 2016
BSD3543 Digital Flat Panel X-ray Detector
K162487
·
MQB
Radiology
·
37d
Cleared
Jun 09, 2016
BSD4343 Digital Flat Panel X-ray Detector
K160204
·
MQB
Radiology
·
133d
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3
Radiology
3