510k
Database
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Anesthesiology
525
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1613
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356
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1304
Ear, Nose, Throat
235
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930
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2136
General Hospital
1991
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126
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91
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8
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449
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942
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429
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272
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2717
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52
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515
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2353
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155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
FXX
Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
264
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Wuxi Nest Biotechnology Co., Ltd.
Medical Device Manufacturer
·
CN , Wuxi
Wuxi Nest Biotechnology Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2021
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wuxi Nest Biotechnology Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 15, 2024
Disposable Pen Injector Assembly
K240961
·
FMF
General Hospital
·
129d
Cleared
Jun 18, 2024
Pen Injector
K240774
·
FMF
General Hospital
·
89d
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4
General Hospital
2
Microbiology
2