510k
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Specialties
Anesthesiology
510
Cardiovascular
1585
Chemistry
355
Dental
1279
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2111
General Hospital
1873
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
930
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421
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267
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2681
Pathology
50
Physical Medicine
507
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2294
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
386
LLZ
System, Image Processing,...
358
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
FXX
Mask, Surgical
279
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Shenzhen Siken 3D Technology Development Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen Siken 3D Technology Development Co., Ltd. - FDA 510(k) Clear...
6 submissions
·
6 cleared
·
Since 2017
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Siken 3D Technology Development Co., Ltd.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 23, 2025
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003...
K252146
·
NFO
Neurology
·
167d
Cleared
Jun 02, 2017
Galvanic Spa, Model: SKB-1405
K163470
·
NFO
Neurology
·
172d
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6
General & Plastic Surgery
4
Neurology
2