510(k) Report

FDA applicant

I.Z.I. Medical Products Corp.

Owings Mills, MD10 decisions1996–20190 recalls

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, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

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

2010: 12014: 12015: 22016: 12019: 1
2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — I.Z.I. Medical Products Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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