Medela, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Medela, LLC - FDA 510(k) Cleared Devices
Recent clearances: Freestyle Mini Hands-free, Motion InBra (YM-8801) wearable breast pump, Pump In Style® Pro+
7
Total
7
Cleared
0
Denied
Medela, LLC has 7 FDA 510(k) cleared medical devices. Based in Mchenry, US.
Latest FDA clearance: Apr 2026. Active since 2018. Primary specialty: Obstetrics & Gynecology.
Browse the FDA 510(k) cleared devices submitted by Medela, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Medela AG as regulatory consultant.
FDA 510(k) Regulatory Record - Medela, LLC
7 devices
Cleared
Apr 10, 2026
Freestyle Mini Hands-free
Obstetrics & Gynecology
156d
Cleared
Feb 13, 2026
Motion InBra (YM-8801) wearable breast pump
Obstetrics & Gynecology
141d
Cleared
Jan 22, 2026
Pump In Style® Pro+
Obstetrics & Gynecology
85d
Cleared
Apr 12, 2024
Duo Hands-free Breast Pump
Obstetrics & Gynecology
228d
Cleared
Aug 11, 2021
Solo, Swing Maxi
Obstetrics & Gynecology
149d
Cleared
Jun 15, 2020
Pump In Style
Obstetrics & Gynecology
105d
Cleared
Oct 16, 2018
Pump In Style Advanced, Advanced Personal Double Breastpump
Obstetrics & Gynecology
89d