FDA applicant
Navarre Biomedical, Ltd.
FDA records 9 decisions for Navarre Biomedical, Ltd. (Plymouth, MN) from 1994 to 1996: 9 510(k) clearances. Most are in product codes GBX (Catheter, Irrigation) and KRA (Catheter, Continuous Flush). 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 Navarre Biomedical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Navarre Biomedical, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Navarre Biomedical, 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) Report