FDA applicant

Berkley Medical Resources, Inc.

Asheville, NC2 decisions1996–19970 recalls

FDA records 2 decisions for Berkley Medical Resources, Inc. (Asheville, NC) from 1996 to 1997: 2 510(k) clearances. All are in product code FXX (Mask, 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 Berkley Medical Resources, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Berkley Medical Resources, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Berkley Medical Resources, 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 “Berkley”

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

Berkley and Co. 3

Berkley Medical Resources, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Berkley”