Unomedical A/S
Unomedical A/S holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2021, with 6 FDA device recalls on record.
Top product codes for Unomedical A/S
FDA recalls by Unomedical A/S
- Z-3186-2024 — VariSoft Infusion Set, Single Use.
- Z-1544-2024 — Neria Soft Infusion Set, Product Code 507302, intravascular administration set
- Z-0234-2024 — VariSoft infusion set, Model Number 1002830
- Z-0233-2024 — VariSoft infusion set, Model Number 1002828
- Z-0232-2024 — VariSoft infusion set, Model Number 1002827
- Z-1810-2022 — Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Unomedical A/S
- K210544 — Medtronic Extended infusion set
- K192647 — neria guard Infusion Set
- K173879 — MiniMed Mio Advance infusion set
- 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 Set
- K160648 — MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
- K132142 — NERIA SOFT 90 INFUSION SET
- K120337 — I-PORT ADVANCE INJECTION PORT
- K070430 — PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS
- K061374 — INTUITION INFUSION SETS
- K051264 — COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
- K041545 — CONTACT DETACH
- K040633 — CLICK-ON
- K032854 — UNOMEDICAL MONICA INFUSION SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.