FDA applicant

Dornier Medtech Systems

Kennesaw, GA1 decision2013–20130 recalls

FDA records 1 decision for Dornier Medtech Systems (Kennesaw, GA) in 2013: 1 510(k) clearance. All are in product code LNS (Lithotriptor, Extracorporeal Shock-Wave…). Its devices cite 2 predicates, 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, gastroenterology and urology panel, where it files most

How often FDA has decided Dornier Medtech Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Dornier Medtech Systems by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dornier Medtech Systems’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.

Dornier Medtech America, Inc. 49 Dornier Surgical Products, Inc. 9 Dornier 3 Dornier Medtech America Inc (Dmta) 1

Dornier Medtech Systems

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Dornier”