SIMPLIVIA HEALTHCARE LTD.
SIMPLIVIA HEALTHCARE LTD. appears in FDA public data with 1 recall, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1057-2022, Class II) was initiated on March 8, 2022. Its most recent 510(k) clearance was granted on October 21, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1057-2022 | Class II | OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 | March 8, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | October 21, 2025 |
| K251411 | Chemfort Female Luer Lock Adaptor | August 5, 2025 |
| K231286 | Chemfort® Catheter Adaptor | August 2, 2023 |
| K210707 | OnGuard2 Chemfort Closed Administration (CADM) | September 23, 2021 |
| K201142 | TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with | February 25, 2021 |
| K192866 | Chemfort CSTD | May 7, 2020 |