FDA applicant

Five Star Medical, Inc.

Charlottesville, VA2 decisions1996–19970 recalls

FDA records 2 decisions for Five Star Medical, Inc. (Charlottesville, VA) from 1996 to 1997: 2 510(k) clearances. Most are in product codes ODF (Mini Endoscope, Gastroenterology-Urology) and EOB (Nasopharyngoscope (Flexible Or Rigid)). 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 Five Star Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Five Star Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Five”

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

Five Star Orthodontic Lab & Supply 1 Five Lakes Co., Inc. 1 Five Stars Alloys, Ltd. 1 Five Star Rubber Products 1

Five Star Medical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Five”