FDA applicant
Scandia Manufacturing, Ltd.
FDA records 1 decision for Scandia Manufacturing, Ltd. (Bloomington, MN) in 2002: 1 510(k) clearance. All are in product code IMB (Cabinet, Moist Steam). 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Scandia Manufacturing, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Scandia Manufacturing, Ltd. since 2007.
Recalls per year
5in 2007
Class I Class II/III not classified
Planning a device like Scandia Manufacturing, 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) ReportOther applicant names beginning “Scandia”
FDA records each applicant name separately; these may or may not be the same firm.