510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1627
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
942
General & Plastic Surgery
2148
General Hospital
2017
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
458
Neurology
946
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2762
Pathology
52
Physical Medicine
515
Radiology
2356
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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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) Regulatory Record - 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