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 its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Ypsomed with 12 510(k) clearances. The most recent is a 510(k) clearance dated Aug 28, 2025: SmartPilot YpsoMate NS-A2.25.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 28, 2025 | SmartPilot YpsoMate NS-A2.25K243901 · QOG | 510(k) clearances |
| Oct 11, 2017 | Clickfine Pen Needle, Penfine Classic Pen NeedleK171984 · FMI | 510(k) clearances |
| Jul 26, 2017 | Orbit InserterK163400 · KZH | 510(k) clearances |
| Apr 12, 2016 | Orbit Infusion SetK150921 · FPA | 510(k) clearances |
| Nov 18, 2015 | Clickfine AutoProtect Pen NeedleK152514 · FMI | 510(k) clearances |
| Jun 9, 2015 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)K150662 · FMI | 510(k) clearances |
| Jul 5, 2013 | CLICKFINE AUTOPROTECT PEN NEEDLEK131123 · FMI | 510(k) clearances |
| Jul 5, 2013 | CLICKFINE PEN NEEDLEK131125 · FMI | 510(k) clearances |
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
