Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Avanos Medical, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories4
Latest FDA decision2025-01-31

SEC Filings: 1 filings on record. Latest: 8-K (2026-07-22). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K243572 Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, LaIRP2025-01-31 View
510(k) K241185 CORGRIP* SR NG/NI Tube Retention SystemKNT2024-10-25 View
510(k) K242057 COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)GXD2024-08-14 View
510(k) K240965 CORTRAK* 2 Enteral Access System (20-0950)KNT2024-06-06 View
510(k) K220588 Avanos* CORTRAK* 2 Enteral Access System (EAS)KNT2022-04-22 View
510(k) K203066 COOLIEF Cooled Radiofrequency Kit AdvancedGXI2020-12-22 View
510(k) K192491 Coolief Radiofrequency Generator (CRG) SystemGXD2020-02-21 View
510(k) K191340 CORTRAK* 2 Equilateral Enteral Access SystemKNT2019-06-04 View
↑