510k
Database
Specialties
Anesthesiology
493
Cardiovascular
1526
Chemistry
348
Dental
1202
Ear, Nose, Throat
222
Gastroenterology & Urology
884
General & Plastic Surgery
2004
General Hospital
1547
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
437
Neurology
870
Obstetrics & Gynecology
386
Ophthalmic
254
Orthopedic
2608
Pathology
49
Physical Medicine
471
Radiology
2178
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
326
LLZ
System, Image Processing,...
322
LZA
Polymer Patient Examination Glove
297
GEI
Electrosurgical, Cutting &...
279
QIH
Automated Radiological Image...
264
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
254
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
187
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Hirata Sangyo Co. USA, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Hirata Sangyo Co. USA, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1982
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hirata Sangyo Co. USA, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 19, 1986
SR-MODEL 230 (MODIFICATION)
K864106
·
FRN
General Hospital
·
29d
Cleared
Jul 25, 1984
SR- MODEL 230
K842289
·
FRN
General Hospital
·
47d
Cleared
Oct 08, 1982
SYRINGE PUMP
K822571
·
FRN
General Hospital
·
45d
Filters
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8
General Hospital
3
Cardiovascular
2
General & Plastic Surgery
2
Orthopedic
1