FDA applicant
Marbex, Inc.
FDA records 4 decisions for Marbex, Inc. (Mchenry, IL) in 1984: 4 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FMF (Syringe, Piston). 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 Marbex, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Marbex, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Marbex, Inc.’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