FDA applicant

North Coast Medi-Tek

Mentor, OH6 decisions1985–19873 recalls

FDA records 6 decisions for North Coast Medi-Tek (Mentor, OH) from 1985 to 1987: 6 510(k) clearances. Most are in product codes FPK (Tubing, Fluid Delivery) and DQO (Catheter, Intravascular, Diagnostic). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided North Coast Medi-Tek’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for North Coast Medi-Tek since 2007.

Recalls per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — North Coast Medi-Tek by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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North Coast Medi-Tek

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?