FDA applicant
Annex Medical, Inc.
FDA records 23 decisions for Annex Medical, Inc. (Eden Prairie, MN) from 1989 to 1995: 23 510(k) clearances. Most are in product codes FFL (Dislodger, Stone, Basket, Ureteral, Metal) and FGO (Dislodger, Stone, Flexible). 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 Annex Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Annex Medical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Annex Medical, 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) Report