FDA applicant
Medinol, Ltd.
FDA records 9 decisions for Medinol, Ltd. (Tel Aviv, IL) from 1998 to 2018: 6 510(k) clearances and 3 original PMA approvals. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and LOX (Catheters, Transluminal Coronary Angioplasty…). Since 2016 its 510(k)s took a median of 141 days from receipt to decision, against 80 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 1 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 Medinol, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medinol, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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