FDA applicant
By-Pass Makafim, Ltd.
FDA records 1 decision for By-Pass Makafim, Ltd. (Washington, DC) in 2004: 1 510(k) clearance. All are in product code FZP (Clip, Implantable). Its devices cite 1 predicate, 0 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 By-Pass Makafim, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for By-Pass Makafim, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like By-Pass Makafim, 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