FDA applicant

Mikro-Tek Laboratories

Bloomington, IN3 decisions1989–19890 recalls

FDA records 3 decisions for Mikro-Tek Laboratories (Bloomington, IN) in 1989: 3 510(k) clearances. All are in product code GBX (Catheter, Irrigation). 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, general and plastic surgery panel, where it files most

How often FDA has decided Mikro-Tek Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mikro-Tek Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Mikro-Tek Laboratories

Which product codes does it file in?

What has FDA decided for it lately?