510k
Database
Specialties
Anesthesiology
417
Cardiovascular
1255
Chemistry
310
Dental
957
Ear, Nose, Throat
181
Gastroenterology & Urology
745
General & Plastic Surgery
1615
General Hospital
1002
Hematology
114
Immunology
80
Medical Genetics
6
Microbiology
405
Neurology
701
Obstetrics & Gynecology
308
Ophthalmic
189
Orthopedic
2271
Pathology
43
Physical Medicine
378
Radiology
1834
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
269
LLZ
System, Image Processing,...
256
QIH
Automated Radiological Image...
238
IYN
System, Imaging, Pulsed Doppler,...
226
GEI
Electrosurgical, Cutting &...
225
HRS
Plate, Fixation, Bone
223
OLO
Orthopedic Stereotaxic Instrument
187
NHA
Abutment, Implant, Dental,...
172
NKB
Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
153
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Fukuda Denshi USA, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Fukuda Denshi USA, Inc. - FDA 510(k) Cleared Devices
68 submissions
·
68 cleared
·
Since 1984
68
Total
68
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fukuda Denshi USA, Inc.
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
May 26, 1987
MODEL U-1000 WITH GESTATIONAL AGE CALCULATION
K871385
·
HGM
Obstetrics & Gynecology
·
49d
Cleared
Sep 27, 1985
MODEL U-1000 ULTRASONIC SCANNER
K851902
·
HEM
Obstetrics & Gynecology
·
150d
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All
68
Cardiovascular
50
Anesthesiology
9
Radiology
7
Obstetrics & Gynecology
2