510k
Database
Specialties
Anesthesiology
534
Cardiovascular
1649
Chemistry
359
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
956
General & Plastic Surgery
2174
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
954
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Fujifilm Corporaton
Medical Device Manufacturer
·
JP , Tokyo
Fujifilm Corporaton - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2020
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fujifilm Corporaton
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 02, 2021
FUJIFILM Video Laparoscope EL-R740M30
K212950
·
GCJ
General & Plastic Surgery
·
77d
Cleared
Jun 30, 2021
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
K203717
·
GCJ
General & Plastic Surgery
·
191d
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6
Gastroenterology & Urology
2
General & Plastic Surgery
2
Radiology
1
Ear, Nose, Throat
1