Medela AG is one of 92 FDA 510(k) medical device manufacturers from Switzerland in the dataset, ranked by real submission volume.
Medela AG - FDA 510(k) Cleared Devices
Recent clearances: Magic InBra, Invia® Integrated Dressing, Invia Ease Negative Pressure Wound Therapy (NPWT) System
30
Total
30
Cleared
0
Denied
Medela AG has 30 FDA 510(k) cleared general & plastic surgery devices. Based in Ch-6340 Baar, CH.
Latest FDA clearance: Sep 2025. Active since 2002.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Hyman, Phelps & McNamara, P.C., Hyman, Phelps, & Mcnamara and Medela, LLC.
FDA 510(k) Regulatory Record - Medela AG
30 devices
Cleared
Sep 18, 2025
Magic InBra
Obstetrics & Gynecology
139d
Cleared
Jul 07, 2023
Invia® Integrated Dressing
General & Plastic Surgery
242d
Cleared
Jul 26, 2022
Invia Ease Negative Pressure Wound Therapy (NPWT) System
General & Plastic Surgery
208d
Cleared
Oct 17, 2019
Freestyle Flex
Obstetrics & Gynecology
119d
Cleared
Feb 01, 2019
Invia Abdominal Dressing Kit
General & Plastic Surgery
172d
Cleared
Nov 02, 2018
Invia White Foam NPWT
General & Plastic Surgery
260d
Cleared
May 09, 2018
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound...
General & Plastic Surgery
296d
Cleared
Apr 06, 2017
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad,...
General & Plastic Surgery
86d
Cleared
Dec 01, 2016
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia...
General & Plastic Surgery
224d
Cleared
May 18, 2016
Vario 8/18/ci
General & Plastic Surgery
149d
Cleared
Nov 05, 2015
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump,...
Obstetrics & Gynecology
141d
Cleared
Oct 07, 2015
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam...
General & Plastic Surgery
148d