510k
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Anesthesiology
534
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1644
Chemistry
359
Dental
1323
Ear, Nose, Throat
243
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956
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2174
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2037
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126
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97
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8
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462
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952
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Nanjing Jin Bai HE Medical Apparatus Co., Ltd.
Medical Device Manufacturer
·
CN , Nanjing
Nanjing Jin Bai HE Medical Apparatus Co., Ltd. - FDA 510(k) Cleared D...
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nanjing Jin Bai HE Medical Apparatus Co., Ltd.
Physical Medicine
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 25, 2021
Scooter (Model: FDB01)
K201196
·
INI
Physical Medicine
·
417d
Cleared
Aug 09, 2017
Powered Wheelchair DYW30A(D09)
K170787
·
ITI
Physical Medicine
·
146d
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2
Physical Medicine
2