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
NKB
Thoracolumbosacral Pedicle Screw...
77
MBI
Fastener, Fixation,...
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.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 06, 2004
RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822
·
LRK
Dental
·
58d
Cleared
Feb 06, 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823
·
LRK
Dental
·
58d
Filters
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All
172
Anesthesiology
154
Neurology
7
Ear, Nose, Throat
2
Chemistry
2
Dental
2
Cardiovascular
2
Physical Medicine
1
Gastroenterology & Urology
1
General Hospital
1