FDA applicant
Elan Medical Technologies, Ltd.
FDA records 2 decisions for Elan Medical Technologies, Ltd. (Gainesville, GA) in 1994: 2 510(k) clearances. All are in product code FRN (Pump, Infusion). 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 Elan Medical Technologies, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Elan Medical Technologies, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Elan Medical Technologies, Ltd.’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 “Elan”
FDA records each applicant name separately; these may or may not be the same firm.