510(k) Report

FDA applicant

Norland Medical Systems, Inc.

Fort Atkinson, WI3 decisions1999–20001 recall

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, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

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

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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.

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Other applicant names beginning “Norland”

FDA records each applicant name separately; these may or may not be the same firm.