510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
NHA
Abutment, Implant, Dental,...
80
MAX
Intervertebral Fusion Device...
80
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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About
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Masimo Corporation
Medical Device Manufacturer
·
US , Irvine , CA
Masimo Corporation - FDA 510(k) Cleared Devices
84 submissions
·
82 cleared
·
Since 2004
84
Total
82
Cleared
2
Denied
FDA 510(k) cleared devices by Masimo Corporation
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 07, 2019
Masimo O3 Regional Oximeter System
K182429
·
MUD
Neurology
·
274d
Cleared
Jan 26, 2018
SedLine Sedation Monitor
K172890
·
OLW
Neurology
·
126d
Filters
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84
Anesthesiology
62
Cardiovascular
16
General & Plastic Surgery
3
Neurology
2
General Hospital
1