510(k) Report

FDA applicant

Western M/D, Inc.

Burlingame, CA2 decisions1991–19940 recalls

FDA records 2 decisions for Western M/D, Inc. (Burlingame, CA) from 1991 to 1994: 2 510(k) clearances. Most are in product codes EKJ (Burnisher, Operative) and ECB (Unit, Syringe, Air And/Or Water). 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, dental panel, where it files most

How often FDA has decided Western M/D, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Western M/D, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Western M/D, 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 “Western”

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