FDA applicant

Alba Health Care

Valdese, NC8 decisions1981–19870 recalls

FDA records 8 decisions for Alba Health Care (Valdese, NC) from 1981 to 1987: 8 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and NAD (Dressing, Wound, Occlusive). 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 Alba Health Care’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alba Health Care since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Alba”

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

Alba-Waldensian, Inc. 8 Alba Critical Care, Ltd. 1

Alba Health Care

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Alba”