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Simplivia Healthcare , Ltd.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories1
Latest FDA decision2025-10-21
TypeNumberDevice NameCodeDateActions
510(k) K253033 Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorONB2025-10-21 View
510(k) K251411 Chemfort Female Luer Lock AdaptorONB2025-08-05 View
510(k) K231286 Chemfort® Catheter AdaptorONB2023-08-02 View
510(k) K210707 OnGuard2 Chemfort Closed Administration (CADM)ONB2021-09-23 View
510(k) K201142 TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety setONB2021-02-25 View
510(k) K192866 Chemfort CSTDONB2020-05-07 View