510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1672
Chemistry
362
Dental
1335
Ear, Nose, Throat
245
Gastroenterology & Urology
964
General & Plastic Surgery
2190
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2900
Pathology
52
Physical Medicine
515
Radiology
2433
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Aerin Medical, Inc.
Medical Device Manufacturer
·
US , Sunnyvale , CA
Aerin Medical, Inc. - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 2015
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aerin Medical, Inc.
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 29, 2022
RhinAer® Stylus (FG1393)
K221907
·
GEI
Ear, Nose, Throat
·
29d
Cleared
Apr 13, 2020
VivAer Stylus
K200300
·
GEI
Ear, Nose, Throat
·
67d
Cleared
Dec 20, 2019
RHIN1 Stylus
K192471
·
GEI
Ear, Nose, Throat
·
101d
Filters
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9
General & Plastic Surgery
5
Ear, Nose, Throat
3
Anesthesiology
1