FDA applicant

Healthtronics Surgical Services, Inc.

Marietta3 decisions1988–20010 recalls

FDA records 3 decisions for Healthtronics Surgical Services, Inc. (Marietta) from 1988 to 2001: 2 510(k) clearances and 1 original PMA approval. Most are in product codes LNS (Lithotriptor, Extracorporeal Shock-Wave…) and JFB (Table, Physical Therapy, Multi Function). 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 Healthtronics Surgical Services, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Healthtronics Surgical Services, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Healthtronics Surgical Services, 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 “Healthtronics”

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

Healthtronics 4

Healthtronics Surgical Services, 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 “Healthtronics”