FDA applicant

Gettner Enterprises, Inc.

Mchenry, IL1 decision1980–19800 recalls

FDA records 1 decision for Gettner Enterprises, Inc. (Mchenry, IL) in 1980: 1 510(k) clearance. All are in product code FMR (Device, Transfer, Patient, Manual). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Gettner Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gettner Enterprises, 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

Gettner Enterprises, Inc.

Which product codes does it file in?

What has FDA decided for it lately?