FDA applicant

Innovations by Necessity, Inc.

Corona Del Mar, CA1 decision1990–19900 recalls

FDA records 1 decision for Innovations by Necessity, Inc. (Corona Del Mar, CA) in 1990: 1 510(k) clearance. All are in product code EMX (Balloon, Epistaxis). 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 Innovations by Necessity, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innovations by Necessity, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innovations by Necessity, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Innovations”

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

Innovations For Mechanical Ventilation, Inc. 3 Innovations IN Access, Inc. 1 Innovations For Access, Inc. 1

Innovations by Necessity, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Innovations”