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Medela AG

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories0
Latest FDA decision
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
510(k) K130123 BASIC AND DOMINANT FLEX SUCTION PUMPSBTA2013-10-11 View
510(k) K130210 MEDELA THOPAZBTA2013-03-15 View
510(k) K113678 INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEMOMP2012-10-01 View
510(k) K080357 MEDELA INVIA WOUND THERAPYOMP2008-07-24 View
510(k) K080212 MEDELA THOPAZ, MODEL 200 0288BTA2008-07-23 View
510(k) K063336 MEDELA DOMINANT 50 LIPO, MODEL 600-5706QPB2007-02-26 View
510(k) K061205 MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATORBTA2006-06-21 View
510(k) K061435 MEDELA VARIO SUCTION PUMPSOMP2006-06-08 View
510(k) K053052 MEDELA SWING BREAST PUMPHGX2006-05-02 View
510(k) K041579 MEDELA SINGLE USE SILC CUP, MODEL 077.0791HDB2005-04-21 View
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