510(k) Report

FDA applicant

Medifix, Inc.

Morton Grove, IL4 decisions1999–20010 recalls

FDA records 4 decisions for Medifix, Inc. (Morton Grove, IL) from 1999 to 2001: 4 510(k) clearances. Most are in product codes FGB (Ureteroscope And Accessories, Flexible/Rigid) and HRX (Arthroscope). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Medifix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medifix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medifix, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medifix, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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