FDA applicant
Mentor Medical Limited
FDA records 1 decision for Mentor Medical Limited (Hyth, Kent, GB) in 2003: 1 510(k) clearance. All are in product code JOH (Tube Tracheostomy And Tube Cuff). Its devices cite 7 predicates, 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 Mentor Medical Limited’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Mentor Medical Limited since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Mentor Medical Limited’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) ReportOther applicant names beginning “Mentor”
FDA records each applicant name separately; these may or may not be the same firm.