510(k) Report

FDA applicant

Graham Medical Products

Holyoke, MA9 decisions1986–19930 recalls

FDA records 9 decisions for Graham Medical Products (Holyoke, MA) from 1986 to 1993: 9 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FRG (Wrap, Sterilization). 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 and plastic surgery panel, where it files most

How often FDA has decided Graham Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Graham Medical Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Graham”

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