510k
Database
Specialties
Anesthesiology
140
Cardiovascular
577
Chemistry
167
Dental
324
Ear, Nose, Throat
68
Gastroenterology & Urology
294
General & Plastic Surgery
534
General Hospital
382
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
67
Ophthalmic
52
Orthopedic
1301
Pathology
18
Physical Medicine
88
Radiology
886
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
135
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
LNH
System, Nuclear Magnetic...
83
JAK
System, X-ray, Tomography, Computed
79
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Imani Co.
Medical Device Manufacturer
·
KR , Yongin-Si
Imani Co. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Imani Co.
Obstetrics & Gynecology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 03, 2023
imani i2Plus Breast Pump
K222573
·
HGX
Obstetrics & Gynecology
·
190d
Cleared
Mar 01, 2021
imani i2
K202037
·
HGX
Obstetrics & Gynecology
·
221d
Cleared
Feb 26, 2021
imani i1
K202045
·
HGX
Obstetrics & Gynecology
·
218d
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3
Obstetrics & Gynecology
3