Company · IL
Simplivia Healthcare , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2025 | K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor Simplivia Healthcare , Ltd., IL | ONB |
| Aug 5, 2025 | K251411 | Chemfort Female Luer Lock Adaptor Simplivia Healthcare , Ltd., IL | ONB |
| Aug 2, 2023 | K231286 | Chemfort® Catheter Adaptor Simplivia Healthcare , Ltd., IL | ONB |
| Sep 23, 2021 | K210707 | OnGuard2 Chemfort Closed Administration (CADM) Simplivia Healthcare , Ltd., IL | ONB |
| Feb 25, 2021 | K201142 | TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTO Simplivia Healthcare , Ltd., IL | ONB |
| May 7, 2020 | K192866 | Chemfort CSTD Simplivia Healthcare , Ltd., IL | ONB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2022 | SIMPLIVIA HEALTHCARE LTD. OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 Open, Classified |
ONB | K192866 |