510k
Database
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Anesthesiology
550
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1723
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385
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1384
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255
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989
General & Plastic Surgery
2225
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2093
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127
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103
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474
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985
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443
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284
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3058
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52
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515
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2503
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155
Categories
LZA
Polymer Patient Examination Glove
418
LLZ
System, Image Processing,...
401
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Powered Laser Surgical Instrument
363
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Mask, Surgical
359
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Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
298
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Unilam Co., Ltd.
Medical Device Manufacturer
·
KR , Ulsan Gwangyeogsi
Unilam Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2015
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Unilam Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 15, 2023
Tanning Lamp
K221523
·
LEJ
General & Plastic Surgery
·
265d
Cleared
Apr 02, 2015
Tanning Lamp
K143043
·
LEJ
General & Plastic Surgery
·
162d
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2
General & Plastic Surgery
2