FDA applicant
Dornier Surgical Products, Inc.
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
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.
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.
See the 510(k) ReportOther applicant names beginning “Dornier”
FDA records each applicant name separately; these may or may not be the same firm.