FDA applicant

Banta Healthcare

Crofton, MD1 decision2001–20010 recalls

FDA records 1 decision for Banta Healthcare (Crofton, MD) in 2001: 1 510(k) clearance. All are in product code FYC (Gown, Isolation, 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 Banta Healthcare’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Banta Healthcare since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Banta”

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

Banta Healthcare Group, Ltd. 2

Banta Healthcare

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Banta”