510k
Database
Specialties
Anesthesiology
133
Cardiovascular
569
Chemistry
164
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
288
General & Plastic Surgery
515
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
167
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1292
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Kowa Company , Ltd.
Medical Device Manufacturer
·
JP , Chofu-Shi
Kowa Company , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Kowa Company , Ltd.
Ophthalmic
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 21, 2022
Kowa SL-19
K222372
·
HJO
Ophthalmic
·
108d
Cleared
Sep 10, 2019
KOWA nonmyd 8
K191945
·
HKI
Ophthalmic
·
50d
Cleared
Jun 04, 2019
KOWA DR-1a
K190573
·
HKI
Ophthalmic
·
90d
Filters
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3
Ophthalmic
3