FDA applicant
Medtronic Blood Systems, Inc.
FDA records 15 decisions for Medtronic Blood Systems, Inc. (Anaheim, CA) from 1988 to 1995: 15 510(k) clearances. Most are in product codes KRJ (Filter, Prebypass, Cardiopulmonary Bypass) and DTZ (Oxygenator, Cardiopulmonary Bypass). 10 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medtronic Blood Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Medtronic Blood Systems, Inc. since 2007.
Recalls per year
1in 2018
Class I Class II/III not classified
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