510(k) Report

FDA applicant

Bfd, Inc.

Gardendale, AL4 decisions1988–19880 recalls

FDA records 4 decisions for Bfd, Inc. (Gardendale, AL) in 1988: 4 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and HOY (Shield, Eye, Ophthalmic (Including Sunlamp…). 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 Bfd, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bfd, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bfd, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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