FDA applicant

Graham-Field, Inc.

Hauppauge, NY8 decisions1989–19970 recalls

FDA records 8 decisions for Graham-Field, Inc. (Hauppauge, NY) from 1989 to 1997: 8 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and GZT (Retractor, Self-Retaining, For Neurosurgery). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Graham-Field, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Graham-Field, 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

Other applicant names beginning “Graham-Field”

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

Graham Medical Products 9 Graham Medical Technologies, LLC Dba Gramedica 2 Graham Medical Technologies, LLC 2 Graham Medical Technologies, LLC (D.B.A.Gramedica) 1 Graham & James 1 Graham Manufacturing Co. 1

Graham-Field, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Graham-Field”