Medela AG is one of 118 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 Tuv America, Inc., Pathway Regulatory Consulting, LLC and Hyman, Phelps & McNamara, P.C..
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