FDA applicant

Regent Medical Americas, LLC

Norcross, GA7 decisions2005–20060 recalls

FDA records 7 decisions for Regent Medical Americas, LLC (Norcross, GA) from 2005 to 2006: 7 510(k) clearances. All are in product code KGO (Surgeon'S Gloves). 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 Regent Medical Americas, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Regent Medical Americas, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Regent Medical Americas, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Regent”

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

Regent Hospital Products 5 Regent Group Co., Ltd. 1 Regent Medical 1

Regent Medical Americas, LLC

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Regent”