FDA applicant

River'S Edge Pharmaceuticals, LLC

Durham, NC1 decision2009–20090 recalls

FDA records 1 decision for River'S Edge Pharmaceuticals, LLC (Durham, NC) in 2009: 1 510(k) clearance. All are in product code NAE (Dressing, Wound, Hydrogel Without Drug And/Or…). Its devices cite 1 predicate, 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, general and plastic surgery panel, where it files most

How often FDA has decided River'S Edge Pharmaceuticals, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — River'S Edge Pharmaceuticals, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “River'S”

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

River Medical, Inc. 16

River'S Edge Pharmaceuticals, LLC

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 “River'S”