510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1611
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2135
General Hospital
1988
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
428
Ophthalmic
272
Orthopedic
2701
Pathology
52
Physical Medicine
514
Radiology
2320
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
368
FXX
Mask, Surgical
354
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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Shenzhen HugeMed Medical Technical Development Co., Ltd.
Medical Device Manufacturer
·
CN , Shenzhen
Shenzhen HugeMed Medical Technical Development Co., Ltd. - FDA 510(k)...
7 submissions
·
7 cleared
·
Since 2023
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen HugeMed Medical Technical Development Co., Ltd.
Ear, Nose, Throat
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 26, 2024
Rhinolaryngoscope system
K232435
·
EOB
Ear, Nose, Throat
·
256d
Cleared
Apr 11, 2023
Bronchoscope System
K222910
·
EOQ
Ear, Nose, Throat
·
197d
Filters
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7
Gastroenterology & Urology
5
Ear, Nose, Throat
2