510k
Database
Specialties
Anesthesiology
530
Cardiovascular
1642
Chemistry
359
Dental
1314
Ear, Nose, Throat
240
Gastroenterology & Urology
950
General & Plastic Surgery
2164
General Hospital
2029
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
950
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2808
Pathology
52
Physical Medicine
515
Radiology
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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Hony Medical Co., Ltd.
Medical Device Manufacturer
·
CN , Taishan
Hony Medical Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hony Medical Co., Ltd.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 24, 2024
Non-Sterile Ultrasound Transmission Gels
K241789
·
MUI
Radiology
·
33d
Cleared
Jul 03, 2024
Transducer Probe Cover
K241615
·
ITX
Radiology
·
28d
Cleared
Jan 11, 2023
Transducer Probe Cover
K221278
·
ITX
Radiology
·
253d
Cleared
Aug 30, 2022
Ultrasound Transmission Gels
K221999
·
MUI
Radiology
·
54d
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4
Radiology
4