Aerin Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Aerin Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: RhinAer+ Stylus, Aerin Console, Reach Needle
10
Total
10
Cleared
0
Denied
Aerin Medical, Inc. has 10 FDA 510(k) cleared medical devices. Based in Sunnyvale, US.
Latest FDA clearance: May 2026. Active since 2015. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Aerin Medical, Inc. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Aerin Medical, Inc.
10 devices
Cleared
May 18, 2026
RhinAer+ Stylus
Ear, Nose, Throat
90d
Cleared
Dec 10, 2024
Aerin Console
General & Plastic Surgery
98d
Cleared
Mar 21, 2024
Reach Needle
Anesthesiology
51d
Cleared
Jul 29, 2022
RhinAer® Stylus (FG1393)
Ear, Nose, Throat
29d
Cleared
Apr 13, 2020
VivAer Stylus
Ear, Nose, Throat
67d
Cleared
CT
Dec 20, 2019
RHIN1 Stylus
Ear, Nose, Throat
101d
Cleared
Dec 05, 2017
Vivaer ARC Stylus
General & Plastic Surgery
106d
Cleared
Jan 11, 2017
InSeca ARC Stylus, Aerin Console
General & Plastic Surgery
97d
Cleared
Sep 22, 2016
Aerin Medical Stylus
General & Plastic Surgery
65d
Cleared
Nov 19, 2015
Aerin Medical Wand Model FG011
General & Plastic Surgery
253d