510k
Database
Specialties
Anesthesiology
519
Cardiovascular
1600
Chemistry
356
Dental
1297
Ear, Nose, Throat
234
Gastroenterology & Urology
926
General & Plastic Surgery
2126
General Hospital
1957
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
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938
Obstetrics & Gynecology
425
Ophthalmic
271
Orthopedic
2691
Pathology
52
Physical Medicine
510
Radiology
2316
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
401
LLZ
System, Image Processing,...
366
GEX
Powered Laser Surgical Instrument
349
FXX
Mask, Surgical
336
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
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Fuji Systems Corp.
Medical Device Manufacturer
·
US , Mccordsville , IN
Fuji Systems Corp. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2005
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fuji Systems Corp.
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 09, 2012
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
K120781
·
DQY
Cardiovascular
·
147d
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2
Anesthesiology
1
Cardiovascular
1