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
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
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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Respironics, Inc.
Medical Device Manufacturer
·
US , Monroeville , PA
Respironics, Inc. - FDA 510(k) Cleared Devices
172 submissions
·
168 cleared
·
Since 1977
Official Website
172
Total
168
Cleared
0
Denied
FDA 510(k) cleared devices by Respironics, Inc.
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 19, 2001
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
K010052
·
MQM
Chemistry
·
70d
Cleared
Mar 04, 1999
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K983071
·
MQM
Chemistry
·
183d
Filters
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All
172
Anesthesiology
154
Neurology
7
Chemistry
2
Dental
2
Cardiovascular
2
Ear, Nose, Throat
2
Gastroenterology & Urology
1
General Hospital
1
Physical Medicine
1