510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2176
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
959
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2844
Pathology
52
Physical Medicine
515
Radiology
2413
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Airs Medical, Inc.
Medical Device Manufacturer
·
KR , Seoul
Airs Medical, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2021
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Airs Medical, Inc.
Radiology
✕
5
devices
1-5 of 5
Filters
Cleared
Mar 26, 2026
SwiftMR
K253775
·
QIH
Radiology
·
120d
Cleared
Sep 23, 2025
SwiftSight-Brain
K251483
·
QIH
Radiology
·
132d
Cleared
Oct 27, 2023
SwiftMR
K230854
·
LLZ
Radiology
·
213d
Cleared
May 25, 2022
SwiftMR
K220416
·
LLZ
Radiology
·
100d
Cleared
Oct 14, 2021
SwiftMR
K210999
·
LLZ
Radiology
·
195d
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5
Radiology
5