FDA applicant
3M Health Care, Ltd.
FDA records 49 decisions for 3M Health Care, Ltd. (St. Paul, MN) from 1990 to 1996: 49 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and KMF (Bandage, Liquid). Its devices cite 1 predicate, 0 of them its own earlier devices. 15 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, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for 3M Health Care, Ltd. since 2007.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like 3M Health Care, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report