FDA applicant

National-Standard Co.

Gainesville, FL1 decision1990–19900 recalls

FDA records 1 decision for National-Standard Co. (Gainesville, FL) in 1990: 1 510(k) clearance. All are in product code FCI (Punch, Biopsy). 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 National-Standard Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for National-Standard Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — National-Standard Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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National-Standard Co.

Which product codes does it file in?

What has FDA decided for it lately?