FDA applicant

Ni-Med, Inc.

South Lyon, MI3 decisions1987–19980 recalls

FDA records 3 decisions for Ni-Med, Inc. (South Lyon, MI) from 1987 to 1998: 3 510(k) clearances. Most are in product codes KNX (Collector, Urine, (And Accessories) For…) and LRS (I.V. Start Kit). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Ni-Med, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ni-Med, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Ni-Med, Inc.

Which product codes does it file in?

What has FDA decided for it lately?