510k
Database
Specialties
Anesthesiology
142
Cardiovascular
581
Chemistry
167
Dental
325
Ear, Nose, Throat
68
Gastroenterology & Urology
296
General & Plastic Surgery
538
General Hospital
384
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
174
Obstetrics & Gynecology
69
Ophthalmic
52
Orthopedic
1305
Pathology
18
Physical Medicine
88
Radiology
889
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
136
OLO
Orthopedic Stereotaxic Instrument
118
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
84
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Bomei Co, Ltd.
Medical Device Manufacturer
·
TW , Taoyuan City
Bomei Co, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2016
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Bomei Co, Ltd.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 08, 2021
OBS Anchorage Screw, Biokey Anchorage Screw
K202278
·
OAT
Dental
·
150d
Cleared
Feb 09, 2016
OBS Anchorage Screw
K152297
·
OAT
Dental
·
180d
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Dental
2