Medical Device Manufacturer · IL , Kiryat Shmona

Simplivia Healthcare , Ltd.

6 submissions · 6 cleared · Since 2020

Total

Cleared

Denied

Simplivia Healthcare , Ltd. — FDA 510(k) Submissions

Simplivia Healthcare , Ltd. has submitted 6 FDA 510(k) premarket notifications since 2020, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System . Use the specialty filter in the sidebar to narrow results.

6 devices

1–6 of 6

Chemfort? 28-day 20 mm Vial Adaptor and 13 mm Convertor

K253033 · ONB Closed Antineoplastic And... · General Hospital

Oct 2025 29d

Chemfort Female Luer Lock Adaptor

K251411 · ONB Closed Antineoplastic And... · General Hospital

Aug 2025 90d

Chemfort? Catheter Adaptor

K231286 · ONB Closed Antineoplastic And... · General Hospital

Aug 2023 90d

OnGuard2 Chemfort Closed Administration (CADM)