FDA applicant
Mcdowell Ent., Inc.
FDA records 1 decision for Mcdowell Ent., Inc. (Kansas City, MO) in 1989: 1 510(k) clearance. All are in product code LZW (Monitor, Spine Curvature). 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 Mcdowell Ent., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Mcdowell Ent., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Mcdowell Ent., 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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