510k
Database
Specialties
Anesthesiology
1487
Cardiovascular
5383
Chemistry
4488
Dental
3249
Ear, Nose, Throat
533
Gastroenterology & Urology
2859
General & Plastic Surgery
4712
General Hospital
4181
Hematology
1085
Immunology
1351
Medical Genetics
15
Microbiology
2521
Neurology
2000
Obstetrics & Gynecology
1004
Ophthalmic
547
Orthopedic
8411
Pathology
353
Physical Medicine
998
Radiology
5461
Toxicology
1361
Categories
LLZ
System, Image Processing,...
789
HRS
Plate, Fixation, Bone
698
GEI
Electrosurgical, Cutting &...
695
IYN
System, Imaging, Pulsed Doppler,...
632
GEX
Powered Laser Surgical Instrument
532
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
490
LNH
System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
465
NKB
Thoracolumbosacral Pedicle Screw...
448
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
KR
Bontech Co., Ltd.
Medical Device Manufacturer
·
KR , Suwon-Si
Bontech Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
Recent clearances:
BONX805
,
BSD3543W
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bontech Co., Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 12, 2025
BONX805
K243864
·
IZL
Radiology
·
269d
Cleared
Apr 23, 2020
BSD3543W
K200787
·
MQB
Radiology
·
28d
Filters
Filter by Specialty
All
2
Radiology
2