510(k) Report

FDA applicant

Gaylord Solutions, LLC

Gaylord, MI1 decision2023–20230 recalls

FDA records 1 decision for Gaylord Solutions, LLC (Gaylord, MI) in 2023: 1 De Novo grant. All are in product code QVS (Breast Implant Suction Retrieval Device). 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 Gaylord Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Gaylord Solutions, LLC by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QVSBreast Implant Suction Retrieval Device1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN220082Breast Implant Removal Device (BIRD)Gaylord Solutions, LLC · 20231cites it

What has FDA decided for it lately?

  • DEN220082Breast Implant Removal Device (BIRD)Gaylord Solutions, LLC · 2023

The one decision as Gaylord Solutions, LLC →