510k
Database
Specialties
Anesthesiology
1011
Cardiovascular
4199
Chemistry
3201
Dental
2735
Ear, Nose, Throat
461
Gastroenterology & Urology
2285
General & Plastic Surgery
3841
General Hospital
3544
Hematology
773
Immunology
774
Medical Genetics
15
Microbiology
1404
Neurology
1690
Obstetrics & Gynecology
849
Ophthalmic
492
Orthopedic
7238
Pathology
163
Physical Medicine
958
Radiology
4595
Toxicology
1235
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
671
GEI
Electrosurgical, Cutting &...
534
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
431
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
386
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
Home
Manufacturers
US
Sysmex America, Inc.
Medical Device Manufacturer
·
US , Mundelein , IL
Sysmex America, Inc. - FDA 510(k) Cleared Devices
31 submissions
·
31 cleared
·
Since 2003
31
Total
31
Cleared
0
Denied
26
devices
26-26 of 26
Filters
1
2
Cleared
Sep 08, 2003
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED...
K032039
·
GKZ
Hematology
·
69d
1
2
Filters
Filter by Specialty
All
31
Hematology
26
Pathology
4
Chemistry
1