510k
Database
Specialties
Anesthesiology
540
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1660
Chemistry
362
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2177
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
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960
Obstetrics & Gynecology
433
Ophthalmic
274
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2846
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52
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515
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2417
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Shenzhen Dakewe Bio-Engineering Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen Dakewe Bio-Engineering Co., Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Dakewe Bio-Engineering Co., Ltd.
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 19, 2024
OmniTrans Transport System
K240235
·
JSM
Microbiology
·
203d
Cleared
Apr 05, 2023
BioSci™ Disposable Virus Sampling Tubes
K230035
·
JSM
Microbiology
·
90d
Cleared
Jan 19, 2023
Biosci™ Inactivated Transport Medium, Biosci™ ITM
K220059
·
QBD
Microbiology
·
374d
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3
Microbiology
3