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Unomedical A/S

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
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
510(k) K132142 NERIA SOFT 90 INFUSION SETFPA2013-10-08 View
510(k) K120337 I-PORT ADVANCE INJECTION PORTFOZ2012-02-16 View
510(k) K070430 PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETSFPA2007-04-04 View
510(k) K061374 INTUITION INFUSION SETSFPA2006-07-31 View
510(k) K051264 COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPSFPA2005-09-01 View
510(k) K041545 CONTACT DETACHFPA2004-06-30 View
510(k) K040633 CLICK-ONFPA2004-04-01 View
510(k) K032854 UNOMEDICAL MONICA INFUSION SETFPA2003-10-09 View
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