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Avanos Medical, Inc.

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

Total Devices8
Categories4
Latest Approval2025-01-31
TypeNumberDevice NameCodeDate
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, La IRP 2025-01-31 View
510(k) K241185 CORGRIP* SR NG/NI Tube Retention System KNT 2024-10-25 View
510(k) K242057 COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) GXD 2024-08-14 View
510(k) K240965 CORTRAK* 2 Enteral Access System (20-0950) KNT 2024-06-06 View
510(k) K220588 Avanos* CORTRAK* 2 Enteral Access System (EAS) KNT 2022-04-22 View
510(k) K203066 COOLIEF Cooled Radiofrequency Kit Advanced GXI 2020-12-22 View
510(k) K192491 Coolief Radiofrequency Generator (CRG) System GXD 2020-02-21 View
510(k) K191340 CORTRAK* 2 Equilateral Enteral Access System KNT 2019-06-04 View