FDA applicant
3M Health Care, Sarns
FDA records 76 decisions for 3M Health Care, Sarns (Ann Arbor, MI) from 1976 to 1996: 76 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DTZ (Oxygenator, Cardiopulmonary Bypass). Its devices cite 3 predicates, 3 of them its own earlier devices. 181 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided 3M Health Care, Sarns’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for 3M Health Care, Sarns since 2007.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like 3M Health Care, Sarns’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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