Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Simplivia Healthcare Ltd. with 6 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Oct 21, 2025: Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 21, 2025 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorK253033 · ONB | 510(k) clearances |
| Aug 5, 2025 | Chemfort Female Luer Lock AdaptorK251411 · ONB | 510(k) clearances |
| Aug 2, 2023 | Chemfort® Catheter AdaptorK231286 · ONB | 510(k) clearances |
| Mar 8, 2022 | OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143Class II · Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications. | Device recalls |
| Sep 23, 2021 | OnGuard2 Chemfort Closed Administration (CADM)K210707 · ONB | 510(k) clearances |
| Feb 25, 2021 | 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 setK201142 · ONB | 510(k) clearances |
| May 7, 2020 | Chemfort CSTDK192866 · ONB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
