FDA applicant

Advanced Medical, Inc.

Huntington Beach, CA3 decisions1977–19890 recalls

FDA records 3 decisions for Advanced Medical, Inc. (Huntington Beach, CA) from 1977 to 1989: 3 510(k) clearances. Most are in product codes EKW (Broach, Endodontic) and DRS (Transducer, Blood-Pressure, Extravascular). 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, cardiovascular panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Advanced 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

Advanced Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?