510k
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Specialties
Anesthesiology
530
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1642
Chemistry
359
Dental
1314
Ear, Nose, Throat
240
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950
General & Plastic Surgery
2164
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2029
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126
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97
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8
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462
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950
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430
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272
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2808
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52
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515
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2384
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
378
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
279
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
223
MAX
Intervertebral Fusion Device...
207
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Shandong Haidike Medical Products Co., Ltd.
Medical Device Manufacturer
·
CN , Heze
Shandong Haidike Medical Products Co., Ltd. - FDA 510(k) Cleared Devi...
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shandong Haidike Medical Products Co., Ltd.
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 14, 2021
Surgical Face Mask
K210518
·
FXX
General Hospital
·
111d
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3
General & Plastic Surgery
2
General Hospital
1