FDA applicant

Graphic Controls Corp.

Buffalo, NY55 decisions1977–19982 recalls

FDA records 55 decisions for Graphic Controls Corp. (Buffalo, NY) from 1977 to 1998: 55 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and MKJ (Automated External Defibrillators (Non-Wearable)). 2 recalls are linked to its devices, 2 Class I.

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

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

How often FDA has decided Graphic Controls Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Graphic Controls Corp. since 2007.

Recalls per year

2in 2014

2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Graphic Controls 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

Other applicant names beginning “Graphic”

FDA records each applicant name separately; these may or may not be the same firm.

Graphic Controls D.B.A. Vermed 1

Graphic Controls Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Graphic”