510k
Database
Specialties
Anesthesiology
327
Cardiovascular
1055
Chemistry
267
Dental
791
Ear, Nose, Throat
147
Gastroenterology & Urology
617
General & Plastic Surgery
1300
General Hospital
741
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
364
Neurology
556
Obstetrics & Gynecology
240
Ophthalmic
154
Orthopedic
2022
Pathology
38
Physical Medicine
308
Radiology
1561
Toxicology
129
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
207
IYN
System, Imaging, Pulsed Doppler,...
205
QIH
Automated Radiological Image...
203
LLZ
System, Image Processing,...
196
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
167
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
136
NKB
Thoracolumbosacral Pedicle Screw...
132
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Sysmex Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Sysmex Corp. - FDA 510(k) Cleared Devices
18 submissions
·
18 cleared
·
Since 1979
18
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sysmex Corp.
Chemistry
✕
1
devices
1-1 of 1
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Cleared
Feb 08, 1979
SHAKER, MODEL SH-510
K790027
·
JRQ
Chemistry
·
36d
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18
Hematology
15
Pathology
2
Chemistry
1