FDA applicant

Denovo Products, LLC

Fort Myers, FL1 decision2011–20110 recalls

FDA records 1 decision for Denovo Products, LLC (Fort Myers, FL) in 2011: 1 510(k) clearance. All are in product code MPO (Infant Heel Warmer (Chemical Heat Pack)). 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

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

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Other applicant names beginning “Denovo”

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

Denovo Proucts, LLC 1

Denovo Products, LLC

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Denovo”