510k
Database
Specialties
Anesthesiology
133
Cardiovascular
568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
515
General Hospital
372
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
165
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1292
Pathology
18
Physical Medicine
85
Radiology
868
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Spirair, Inc.
Medical Device Manufacturer
·
US , San Jose , CA
Spirair, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2023
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Spirair, Inc.
Ear, Nose, Throat
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 16, 2026
SeptAlign
K251790
·
NHB
Ear, Nose, Throat
·
219d
Cleared
Jul 11, 2025
TurbAlign
K243655
·
LYA
Ear, Nose, Throat
·
227d
Cleared
Mar 22, 2024
SeptAlign
K233569
·
NHB
Ear, Nose, Throat
·
137d
Cleared
Aug 17, 2023
Spirair Nasal Septal Strap
K223167
·
NHB
Ear, Nose, Throat
·
314d
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4
Ear, Nose, Throat
4