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Medela AG

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories3
Latest FDA decision2025-09-18
TypeNumberDevice NameCodeDateActions
510(k) K251377 Magic InBraHGX2025-09-18 View
510(k) K223388 Invia® Integrated DressingOMP2023-07-07 View
510(k) K214112 Invia Ease Negative Pressure Wound Therapy (NPWT) SystemOMP2022-07-26 View
510(k) K191653 Freestyle FlexHGX2019-10-17 View
510(k) K182191 Invia Abdominal Dressing KitOMP2019-02-01 View
510(k) K180415 Invia White Foam NPWTOMP2018-11-02 View
510(k) K172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPadOMP2018-05-09 View
510(k) K170088 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent FilmOMP2017-04-06 View
510(k) K161128 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyOMP2016-12-01 View
510(k) K153663 Vario 8/18/ciBTA2016-05-18 View
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