Unomedical A/S
Medical device manufacturer in Lejre, Denm.
13510(k) clearances
0PMA approvals
6recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K210544 | Medtronic Extended infusion setFPA · Traditional | 07/16/2021SE |
| K192647 | neria guard Infusion SetFPA · Traditional | 12/13/2019SE |
| K173879 | MiniMed Mio Advance infusion setFPA · Traditional | 03/05/2018SE |
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous…FPA · Traditional | 11/01/2017SE |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®FPA · Traditional | 08/10/2016SE |
| K132142 | Neria Soft 90 Infusion SetFPA · Traditional | 10/08/2013SE |
| K120337 | I-Port Advance Injection PortFOZ · Abbreviated | 02/16/2012SE |
| K070430 | Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion SetsFPA · Traditional | 04/04/2007SE |
| K061374 | Intuition Infusion SetsFPA · Traditional | 07/31/2006SE |
| K051264 | Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion PumpsFPA · Traditional | 09/01/2005SE |
| K041545 | Contact DetachFPA · Special | 06/30/2004SE |
| K040633 | Click-OnFPA · Special | 04/01/2004SE |
| K032854 | Unomedical Monica Infusion SetFPA · Special | 10/09/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3186-2024 Class II | VariSoft Infusion Set, Single Use.Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded… | 07/23/2024Open, Classified |
| Z-1544-2024 Class II | Neria Soft Infusion Set, Product Code 507302, intravascular administration setSpecific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped… | 03/05/2024Open, Classified |
| Z-0234-2024 Class I | VariSoft infusion set, Model Number 1002830The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage… | 10/11/2023Open, Classified |
| Z-0233-2024 Class I | VariSoft infusion set, Model Number 1002828The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage… | 10/11/2023Open, Classified |
| Z-0232-2024 Class I | VariSoft infusion set, Model Number 1002827The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage… | 10/11/2023Open, Classified |
| Z-1810-2022 Class II | Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821…The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial… | 07/21/2022Terminated |