510(k) Report

FDA applicant

Annex Medical, Inc.

Eden Prairie, MN23 decisions1989–19950 recalls

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, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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.

FIG. 1 — Annex Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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