FDA applicant
Orphan Medical, Inc.
FDA records 1 decision for Orphan Medical, Inc. (Minnetonka, MN) in 1996: 1 510(k) clearance. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 5 predicates, 0 of them its own earlier devices. 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 Orphan Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Orphan Medical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Orphan 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