510(k) Report

FDA applicant

Macdonald Medical Devices, Inc.

Cheshire, CT1 decision1993–19930 recalls

FDA records 1 decision for Macdonald Medical Devices, Inc. (Cheshire, CT) in 1993: 1 510(k) clearance. All are in product code KNT (Tubes, Gastrointestinal (And Accessories)). 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 Macdonald Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Macdonald Medical Devices, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Macdonald”

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