FDA applicant

Edap International Corp.

Burlington2 decisions1989–19910 recalls

FDA records 2 decisions for Edap International Corp. (Burlington) from 1989 to 1991: 2 original PMA approvals. All are in product code LNS (Lithotriptor, Extracorporeal Shock-Wave…). 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 Edap International Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Edap International Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Edap”

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

Edap Technomed, Inc. 5 Edap Tms France 1

Edap International Corp.

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 “Edap”