FDA applicant

Austin Medical, Inc.

Bonita Springs, FL1 decision2006–20060 recalls

FDA records 1 decision for Austin Medical, Inc. (Bonita Springs, FL) in 2006: 1 510(k) clearance. All are in product code KKX (Drape, Surgical, Antimicrobial). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Austin Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Austin Medical, 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

Other applicant names beginning “Austin”

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

Austin Biological Laboratories 45 Austin Miller Trauma, LLC 1 Austin Assoc. 1 Austin & Associates, Inc./Telos Medical Equipment 1 Austin Medical Ventures, Inc. 1 The Austin-Lenick Co. 1

Austin Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Austin”