FDA applicant
I.Z.I. Medical Products Corp.
FDA records 10 decisions for I.Z.I. Medical Products Corp. (Owings Mills, MD) from 1996 to 2019: 10 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and KPR (System, X-Ray, Stationary). Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Izi Medical Products, LLC”, “Izi Medical Products”, “Izi Medical Products, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided I.Z.I. Medical Products Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like I.Z.I. Medical Products Corp.’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