Total clearances
9
2020-06-15 → 2026-04-10
Name variants in FDA filings: Medela AG / Medela, LLC
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| HGX |
Pump, Breast, Powered |
Class II |
Obstetrics/Gynecology |
7 |
2026-04-10 |
| OMP |
Negative Pressure Wound Therapy Powered Suction Pump |
Class II |
General, Plastic Surgery |
2 |
2023-07-07 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2026-06-05 |
Class II
|
Ongoing |
Z-2645-2026 |
Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 S… |
— |
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery o… |
Filings
All 510(k) clearances (9)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-04-10 |
K253510 |
Freestyle Mini Hands-free |
HGX |
Class II |
Obstetrics/Gynecology |
| 2026-02-13 |
K253149 |
Motion InBra (YM-8801) wearable breast pump |
HGX |
Class II |
Obstetrics/Gynecology |
| 2026-01-22 |
K253498 |
Pump In Style® Pro+ |
HGX |
Class II |
Obstetrics/Gynecology |
| 2025-09-18 |
K251377 |
Magic InBra |
HGX |
Class II |
Obstetrics/Gynecology |
| 2024-04-12 |
K232608 |
Duo Hands-free Breast Pump |
HGX |
Class II |
Obstetrics/Gynecology |
| 2023-07-07 |
K223388 |
Invia® Integrated Dressing |
OMP |
Class II |
General, Plastic Surgery |
| 2022-07-26 |
K214112 |
Invia Ease Negative Pressure Wound Therapy (NPWT) System |
OMP |
Class II |
General, Plastic Surgery |
| 2021-08-11 |
K210759 |
Solo, Swing Maxi |
HGX |
Class II |
Obstetrics/Gynecology |
| 2020-06-15 |
K200508 |
Pump In Style |
HGX |
Class II |
Obstetrics/Gynecology |