Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Unomedical A/S

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories1
Latest FDA decision2021-07-16
TypeNumberDevice NameCodeDateActions
510(k) K210544 Medtronic Extended infusion setFPA2021-07-16 View
510(k) K192647 neria guard Infusion SetFPA2019-12-13 View
510(k) K173879 MiniMed Mio Advance infusion setFPA2018-03-05 View
510(k) K162812 Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion SetFPA2017-11-01 View
510(k) K160648 MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®FPA2016-08-10 View
↑