510k
Database
Specialties
Anesthesiology
136
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572
Chemistry
165
Dental
321
Ear, Nose, Throat
68
Gastroenterology & Urology
291
General & Plastic Surgery
528
General Hospital
379
Hematology
67
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58
Medical Genetics
0
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234
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173
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62
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51
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1297
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18
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88
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876
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Bio Concept Co., Ltd.
Medical Device Manufacturer
·
CN , Changzhou
Bio Concept Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2015
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Bio Concept Co., Ltd.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 10, 2022
BLT Dental Implant System
K212364
·
DZE
Dental
·
376d
Cleared
Jun 18, 2020
BV Dental Implant System
K192274
·
DZE
Dental
·
301d
Cleared
Nov 12, 2015
Dental Implant System
K150388
·
DZE
Dental
·
267d
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3
Dental
3