510(k) Report

FDA applicant

Nieusma R & D, Inc.

Warren, MI3 decisions1989–19890 recalls

FDA records 3 decisions for Nieusma R & D, Inc. (Warren, MI) in 1989: 3 510(k) clearances. Most are in product codes EHZ (Evacuator, Oral Cavity) and EIA (Unit, Operative Dental). No 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, dental panel, where it files most

How often FDA has decided Nieusma R & D, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nieusma R & D, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nieusma R & D, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nieusma R & D, 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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