FDA applicant

Medac, Inc.

Tualatin, OR10 decisions1987–19880 recalls

FDA records 10 decisions for Medac, Inc. (Tualatin, OR) from 1987 to 1988: 10 510(k) clearances. Most are in product codes DRO (Pacemaker, Cardiac, External Transcutaneous…) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). 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 Medac, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medac, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Medac, Inc.

Which product codes does it file in?

What has FDA decided for it lately?