FDA applicant
Bsn Medical, Inc.
FDA records 3 decisions for Bsn Medical, Inc. (Rutherford College, NC) from 2012 to 2015: 3 510(k) clearances. Most are in product codes DWL (Stocking, Medical Support (To Prevent Pooling…) and FRO (Dressing, Wound, Drug). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Bsn Medical GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bsn Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Bsn 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