FDA applicant
Dornier Medtech America, Inc.
FDA records 49 decisions for Dornier Medtech America, Inc. (Kennesaw, GA) from 1984 to 2025: 46 510(k) clearances and 3 original PMA approvals. Most are in product codes GEX (Powered Laser Surgical Instrument) and LNS (Lithotriptor, Extracorporeal Shock-Wave…). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 67 predicates, 28 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Dornier Medtech America”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dornier Medtech America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Dornier Medtech America, 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) ReportOther applicant names beginning “Dornier”
FDA records each applicant name separately; these may or may not be the same firm.