510k
Database
Specialties
Anesthesiology
545
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1709
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380
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1355
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252
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982
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2215
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2079
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126
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100
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8
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474
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980
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441
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282
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3023
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52
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515
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2486
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155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
399
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
290
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
231
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Bioland Technology, Ltd.
Medical Device Manufacturer
·
HK , North Point
Bioland Technology, Ltd. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2009
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bioland Technology, Ltd.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 05, 2022
Infrared Thermometer (model: E201)
K213011
·
FLL
General Hospital
·
197d
Cleared
Mar 31, 2021
Digital Thermometer Model T103, T104
K201879
·
FLL
General Hospital
·
267d
Cleared
Oct 02, 2020
Infrared Thermometer Model E127
K201161
·
FLL
General Hospital
·
155d
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8
Cardiovascular
3
General Hospital
3
Chemistry
2