Avanos Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Avanos Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Game Ready system (550500-04), CORGRIP* SR NG/NI Tube Retention System, COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
8
Total
8
Cleared
0
Denied
Avanos Medical, Inc. has 8 FDA 510(k) cleared medical devices. Based in Alpharetta, US.
Latest FDA clearance: Jan 2025. Active since 2019. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Avanos Medical, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Third Party Review Group, LLC and Accelerated Device Approval Services.
FDA 510(k) Regulatory Record - Avanos Medical, Inc.
8 devices
Cleared
Jan 31, 2025
Game Ready system (550500-04)
Physical Medicine
74d
Cleared
Oct 25, 2024
CORGRIP* SR NG/NI Tube Retention System
Gastroenterology & Urology
179d
Cleared
Aug 14, 2024
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED,...
Neurology
30d
Cleared
Jun 06, 2024
CORTRAK* 2 Enteral Access System (20-0950)
Gastroenterology & Urology
58d
Cleared
Apr 22, 2022
Avanos* CORTRAK* 2 Enteral Access System (EAS)
Gastroenterology & Urology
52d
Cleared
Dec 22, 2020
COOLIEF Cooled Radiofrequency Kit Advanced
Neurology
74d
Cleared
Feb 21, 2020
Coolief Radiofrequency Generator (CRG) System
Neurology
163d
Cleared
Jun 04, 2019
CORTRAK* 2 Equilateral Enteral Access System
Gastroenterology & Urology
15d