510k
Database
Specialties
Anesthesiology
440
Cardiovascular
1340
Chemistry
331
Dental
1035
Ear, Nose, Throat
192
Gastroenterology & Urology
795
General & Plastic Surgery
1756
General Hospital
1163
Hematology
118
Immunology
84
Medical Genetics
7
Microbiology
414
Neurology
751
Obstetrics & Gynecology
331
Ophthalmic
204
Orthopedic
2398
Pathology
44
Physical Medicine
400
Radiology
1939
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
286
LLZ
System, Image Processing,...
277
GEI
Electrosurgical, Cutting &...
249
QIH
Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
233
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
188
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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Hitachi Medical Corp. of America
Medical Device Manufacturer
·
US , Tarrytown , NY
Hitachi Medical Corp. of America - FDA 510(k) Cleared Devices
32 submissions
·
31 cleared
·
Since 1985
32
Total
31
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hitachi Medical Corp. of America
Obstetrics & Gynecology
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 12, 1990
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
K900966
·
HGL
Obstetrics & Gynecology
·
195d
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32
Radiology
27
Cardiovascular
4
Obstetrics & Gynecology
1