510k
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337
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1072
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271
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819
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149
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634
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1331
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765
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100
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72
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1
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366
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587
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246
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155
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2059
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40
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310
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1589
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132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
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Automated Radiological Image...
207
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
160
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
136
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Ningbo Medsun Medical Co., Ltd.
Medical Device Manufacturer
·
CN , Ningbo
Ningbo Medsun Medical Co., Ltd. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2022
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ningbo Medsun Medical Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 18, 2026
Safety Pen Needle
K253622
·
FMI
General Hospital
·
120d
Cleared
Nov 17, 2022
Disposable Insulin Pen Needle
K221178
·
FMI
General Hospital
·
206d
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7
General & Plastic Surgery
5
General Hospital
2