FDA applicant
Flexicath, Ltd.
FDA records 4 decisions for Flexicath, Ltd. (Tel Aviv, IL) from 2007 to 2012: 4 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and LJS (Catheter, Intravascular, Therapeutic…). Its devices cite 8 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Flexicath, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Flexicath, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report