FDA applicant
Nieusma R & D, Inc.
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
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.
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.
See the 510(k) Report