510k
Database
Specialties
Anesthesiology
508
Cardiovascular
1578
Chemistry
355
Dental
1266
Ear, Nose, Throat
233
Gastroenterology & Urology
917
General & Plastic Surgery
2099
General Hospital
1805
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
445
Neurology
920
Obstetrics & Gynecology
418
Ophthalmic
265
Orthopedic
2674
Pathology
49
Physical Medicine
504
Radiology
2284
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
366
LLZ
System, Image Processing,...
353
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
291
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
247
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Haemonetics Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Haemonetics Corp. - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 1980
Official Website
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Haemonetics Corp.
Hematology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 01, 1981
HAEMONETICS 1000ML COMPONENT BAG
K811449
·
KSR
Hematology
·
40d
Cleared
May 08, 1981
HAEMONETICS 600 ML. COMPONENT BAG
K810711
·
KSR
Hematology
·
52d
Cleared
Mar 31, 1981
HAEMONETICS 1400 ML THERAPEUTIC BAG
K810313
·
KSR
Hematology
·
54d
Filters
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28
Anesthesiology
16
General Hospital
5
General & Plastic Surgery
3
Hematology
3
Gastroenterology & Urology
1