Data / Medical devices / Israel / Simplivia Healthcare Ltd.
Simplivia Healthcare Ltd.: FDA-registered device maker in KIRYAT SHMONA Northern, Israel, 6 510(k) clearances
Simplivia Healthcare Ltd. is registered with the FDA (registration 9611423) in KIRYAT SHMONA Northern, Israel. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 5, 2025. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611423
- FEI number
- 3002807615
- Address
- North Ind. Zone P.o.box 888, KIRYAT SHMONA Northern, Israel, 1101801
- Owner or operator
- SIMPLIVIA HEALTHCARE LTD. (9001925)
- Roles
- Manufacturer
- First device listed
- November 4, 2015
- Registered through
- 2027
- Brand names listed
- Chemfort 20mm Vial Adaptor II and 13mm convertor, Chemfort Sterile Caps for Syringe, OnGuard Closed Adaptor SP, OnGuard Spike Port Adaptor, OnGuard2 Bag Adaptor CP, OnGuard2 Bag Adaptor LL, OnGuard2 Bag Adaptor LL with ULTRASITE, OnGuard2 Bag Adaptor SP with ULTRASITE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2025 | K251411 | Chemfort Female Luer Lock Adaptor | ONB | Substantially Equivalent | Simplivia Healthcare , Ltd. | accessdata.fda.gov |
| August 2, 2023 | K231286 | Chemfort® Catheter Adaptor | ONB | Substantially Equivalent | Simplivia Healthcare , Ltd. | accessdata.fda.gov |
| September 23, 2021 | K210707 | OnGuard2 Chemfort Closed Administration (CADM) | ONB | Substantially Equivalent | Simplivia Healthcare , Ltd. | accessdata.fda.gov |
| February 25, 2021 | 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 set | ONB | Substantially Equivalent | Simplivia Healthcare , Ltd. | accessdata.fda.gov |
| May 7, 2020 | K192866 | Chemfort CSTD | ONB | Substantially Equivalent | Simplivia Healthcare , Ltd. | accessdata.fda.gov |
| January 23, 2015 | K141448 | TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | ONB | Substantially Equivalent | Teva Medical Ltd., Migada Plant | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 8, 2022 | 89952 | Class II | Ongoing | OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 | Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications. | accessdata.fda.gov |
| December 18, 2008 | 51421 | Not yet classified | Terminated | TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. Model number is MG412110. The device is a single use dev | Syringe adaptor is disintegrating when attached to the end of the syringe. | accessdata.fda.gov |
Compare with other makers
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Set, Administration, Intravascular
Updated August 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.