510(k) Report

FDA applicant

Ulster Scientific, Inc.

Highland, NY20 decisions1980–19940 recalls

FDA records 20 decisions for Ulster Scientific, Inc. (Highland, NY) from 1980 to 1994: 20 510(k) clearances. Most are in product codes FMK (Single Use Only Blood Lancet With An Integral…) and FMF (Syringe, Piston). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Ulster Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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