FDA applicant
Norland Medical Systems, Inc.
FDA records 3 decisions for Norland Medical Systems, Inc. (Fort Atkinson, WI) from 1999 to 2000: 3 510(k) clearances. All are in product code KGI (Densitometer, Bone). Its devices cite 8 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Norland Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Norland Medical Systems, Inc. since 2007.
Recalls per year
1in 2011
Class I Class II/III not classified
Planning a device like Norland Medical Systems, 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) ReportOther applicant names beginning “Norland”
FDA records each applicant name separately; these may or may not be the same firm.