Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwitzerlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Medela and its 2 subsidiaries with 56 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Apr 10, 2026: Freestyle Mini Hands-free.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Medela and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 10, 2026 | Freestyle Mini Hands-freeK253510 · HGX | 510(k) clearances |
| Feb 13, 2026 | Motion InBra (YM-8801) wearable breast pumpK253149 · HGX | 510(k) clearances |
| Jan 22, 2026 | Pump In Style® Pro+K253498 · HGX | 510(k) clearances |
| Sep 18, 2025 | Magic InBraK251377 · HGX | 510(k) clearances |
| Apr 12, 2024 | Duo Hands-free Breast PumpK232608 · HGX | 510(k) clearances |
| Jul 7, 2023 | Invia® Integrated DressingK223388 · OMP | 510(k) clearances |
| Jul 26, 2022 | Invia Ease Negative Pressure Wound Therapy (NPWT) SystemK214112 · OMP | 510(k) clearances |
| Aug 11, 2021 | Solo, Swing MaxiK210759 · HGX | 510(k) clearances |
| Feb 13, 2015 | - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio EnteClass II · The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products ma | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
