510k
Database
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Anesthesiology
538
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1654
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360
Dental
1323
Ear, Nose, Throat
243
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957
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2175
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2038
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126
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97
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8
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462
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958
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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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) Regulatory Record - 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