FDA applicant

Encompas Unlimited, Inc.

Tierra Verde, FL1 decision1994–19940 recalls

FDA records 1 decision for Encompas Unlimited, Inc. (Tierra Verde, FL) in 1994: 1 510(k) clearance. All are in product code MNK (Endoscopic Bite Block). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Encompas Unlimited, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Encompas Unlimited, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Encompas Unlimited, Inc.

Which product codes does it file in?

What has FDA decided for it lately?