SIMPLIVIA HEALTHCARE LTD.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1057-2022Class IIOnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143March 8, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorOctober 21, 2025
K251411Chemfort Female Luer Lock AdaptorAugust 5, 2025
K231286Chemfort® Catheter AdaptorAugust 2, 2023
K210707OnGuard2 Chemfort Closed Administration (CADM)September 23, 2021
K201142TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with February 25, 2021
K192866Chemfort CSTDMay 7, 2020