FDA applicant
Axiom Medical, Inc.
FDA records 28 decisions for Axiom Medical, Inc. (Mchenry, IL) from 1977 to 2000: 28 510(k) clearances. Most are in product codes GBS (Catheter, Ventricular, General & Plastic Surgery) and GBX (Catheter, Irrigation). 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 Axiom Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Axiom Medical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Axiom Medical, 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) ReportOther applicant names beginning “Axiom”
FDA records each applicant name separately; these may or may not be the same firm.