FDA applicant

Medtronic Hemotec, Inc.

Englewood, CO5 decisions1992–19960 recalls

FDA records 5 decisions for Medtronic Hemotec, Inc. (Englewood, CO) from 1992 to 1996: 5 510(k) clearances. Most are in product codes JBP (Activated Whole Blood Clotting Time) and JPA (System, Multipurpose For In Vitro Coagulation…). 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, hematology panel, where it files most

How often FDA has decided Medtronic Hemotec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Hemotec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Medtronic Hemotec, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?