FDA applicant

National Custom Ent., Inc.

Burnsville, MN12 decisions1993–20010 recalls

FDA records 12 decisions for National Custom Ent., Inc. (Burnsville, MN) from 1993 to 2001: 12 510(k) clearances. Most are in product codes MRZ (Accessories, Pump, Infusion) and DPS (Electrocardiograph). 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, cardiovascular panel, where it files most

How often FDA has decided National Custom Ent., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for National Custom Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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National Custom Ent., Inc.

Which product codes does it file in?

What has FDA decided for it lately?