FDA applicant
Trulife, Ltd.
FDA records 1 decision for Trulife, Ltd. (Dublin 24, IE) in 1993: 1 510(k) clearance. All are in product code GBJ (Prosthesis, Adhesive, External). 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 Trulife, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Trulife, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Trulife, 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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