510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1612
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
928
General & Plastic Surgery
2135
General Hospital
1991
Hematology
126
Immunology
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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2704
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52
Physical Medicine
515
Radiology
2322
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
368
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Oriental Inspiration Limited
Medical Device Manufacturer
·
CN , Hong Kong
Oriental Inspiration Limited - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2017
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Oriental Inspiration Limited
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
May 03, 2017
Hee HR Mini
K170269
·
OHT
General & Plastic Surgery
·
96d
Cleared
Apr 25, 2017
BC-001+ Acne Purifier
K170260
·
OLP
General & Plastic Surgery
·
88d
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5
Neurology
2
General & Plastic Surgery
2
Gastroenterology & Urology
1