510k
Database
Specialties
Anesthesiology
415
Cardiovascular
1254
Chemistry
310
Dental
954
Ear, Nose, Throat
181
Gastroenterology & Urology
745
General & Plastic Surgery
1607
General Hospital
1001
Hematology
114
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80
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6
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403
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700
Obstetrics & Gynecology
308
Ophthalmic
187
Orthopedic
2271
Pathology
43
Physical Medicine
378
Radiology
1832
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
268
LLZ
System, Image Processing,...
256
QIH
Automated Radiological Image...
237
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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Shimadzu Medical Systems
Medical Device Manufacturer
·
US , Gardena , CA
Shimadzu Medical Systems - FDA 510(k) Cleared Devices
90 submissions
·
90 cleared
·
Since 1989
90
Total
90
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shimadzu Medical Systems
Obstetrics & Gynecology
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 06, 1991
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT
K910426
·
HEM
Obstetrics & Gynecology
·
127d
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90
Radiology
89
Obstetrics & Gynecology
1