FDA applicant

Grifols USA, LLC

Los Angeles, CA3 decisions2011–20120 recalls

FDA records 3 decisions for Grifols USA, LLC (Los Angeles, CA) from 2011 to 2012: 3 510(k) clearances. Most are in product codes CFF (Immunoelectrophoretic, Immunoglobulins, (G, A…) and MVM (Autoantibodies, Endomysial (Tissue…). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Grifols USA, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Grifols USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2011high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Grifols USA, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Grifols USA, LLC’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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Other applicant names beginning “Grifols”

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

Grifols 1

Grifols USA, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Grifols”