510k
Database
Specialties
Anesthesiology
544
Cardiovascular
1688
Chemistry
370
Dental
1347
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2204
General Hospital
2052
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
472
Neurology
975
Obstetrics & Gynecology
437
Ophthalmic
279
Orthopedic
2975
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52
Physical Medicine
515
Radiology
2463
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
396
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
222
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Hunan Accurate Bio-Medical Technology Co., Ltd.
Medical Device Manufacturer
·
CN , Changsha, Hunan
Hunan Accurate Bio-Medical Technology Co., Ltd. - FDA 510(k) Cleared ...
5 submissions
·
5 cleared
·
Since 2014
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hunan Accurate Bio-Medical Technology Co., Ltd.
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 27, 2026
Pelvic Floor Exerciser (PF01)
K252748
·
HIR
Gastroenterology & Urology
·
241d
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5
Anesthesiology
4
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1