FDA applicant

Innovia Medical, LLC

Littleton, CO1 decision2007–20070 recalls

FDA records 1 decision for Innovia Medical, LLC (Littleton, CO) in 2007: 1 510(k) clearance. All are in product code ETY (Tester, Auditory Impedance). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innovia Medical, 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 “Innovia”

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

Innovia, LLC 3

Innovia Medical, LLC

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Innovia”