FDA applicant

Ames Medical Prosthetic Solutions, S.A.U.

Sant Feliu De Llobregat, ES1 decision2024–20240 recalls

FDA records 1 decision for Ames Medical Prosthetic Solutions, S.A.U. (Sant Feliu De Llobregat, ES) in 2024: 1 510(k) clearance. All are in product code PLF (Bone Wedge). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, orthopedic panel, where it files most

How often FDA has decided Ames Medical Prosthetic Solutions, S.A.U.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Ames Medical Prosthetic Solutions, S.A.U. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Ames”

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

Ames Div., Miles Laboratories, Inc. 1 Ames Technology, Inc. 1

Ames Medical Prosthetic Solutions, S.A.U.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ames”