510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1693
Chemistry
370
Dental
1348
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2206
General Hospital
2053
Hematology
126
Immunology
100
Medical Genetics
8
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473
Neurology
980
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438
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280
Orthopedic
2978
Pathology
52
Physical Medicine
515
Radiology
2466
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
398
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
358
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...
224
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Jkh USA, LLC
Medical Device Manufacturer
·
US , Diamond Bar , CA
Jkh USA, LLC - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 2019
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jkh USA, LLC
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 05, 2021
Patient Monitoring Cables
K203635
·
DSA
Cardiovascular
·
53d
Cleared
Jan 06, 2021
Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood...
K203652
·
DXQ
Cardiovascular
·
23d
Filters
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9
Neurology
3
General Hospital
2
Cardiovascular
2
Physical Medicine
1
Anesthesiology
1