FDA applicant

Un-I-Med, Inc.

Largo, FL2 decisions1991–19950 recalls

FDA records 2 decisions for Un-I-Med, Inc. (Largo, FL) from 1991 to 1995: 2 510(k) clearances. Most are in product codes FAS (Electrode, Electrosurgical, Active, Urological) and BSY (Catheters, Suction, Tracheobronchial). 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 Un-I-Med, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Un-I-Med, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Un-I-Med, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Un-I-Med, Inc.

Which product codes does it file in?

What has FDA decided for it lately?