510(k) Report

FDA applicant

Dornier Surgical Products, Inc.

Kennesaw, GA9 decisions1998–20010 recalls

FDA records 9 decisions for Dornier Surgical Products, Inc. (Kennesaw, GA) from 1998 to 2001: 9 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 10 predicates, 2 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 Dornier Surgical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dornier Surgical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dornier Surgical Products, 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 “Dornier”

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