FDA applicant

Spire Medical, Inc.

Ventura, CA5 decisions1980–19820 recalls

FDA records 5 decisions for Spire Medical, Inc. (Ventura, CA) from 1980 to 1982: 5 510(k) clearances. Most are in product codes EQJ (Bur, Ear, Nose And Throat) and GFA (Blade, Saw, General & Plastic Surgery, Surgical). 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 Spire Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spire Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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See the 510(k) Report

Other applicant names beginning “Spire”

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

Spire Biomedical, Inc. 16 Spire, Inc. D/B/A Spire Health 1

Spire Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Spire”