510k
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333
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1068
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270
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809
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148
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628
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1322
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760
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99
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72
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366
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582
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244
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155
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2055
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40
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310
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1585
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132
Categories
GEX
Powered Laser Surgical Instrument
229
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Plate, Fixation, Bone
211
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System, Imaging, Pulsed Doppler,...
208
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Automated Radiological Image...
206
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
169
NHA
Abutment, Implant, Dental,...
158
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
135
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S&M Medical Co., Ltd.
Medical Device Manufacturer
·
KR , Gwangju
S&M Medical Co., Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2026
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - S&M Medical Co., Ltd.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Mar 09, 2026
NeoSculpt Plus
K252888
·
PBX
General & Plastic Surgery
·
180d
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1
General & Plastic Surgery
1