FDA applicant
3M Deutschland GmbH
FDA records 12 decisions for 3M Deutschland GmbH (Seefeld, DE) from 2012 to 2022: 12 510(k) clearances. Most are in product codes ELW (Material, Impression) and PIP (Prophy Powder, Airbrush Accessory). Since 2016 its 510(k)s took a median of 11 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided 3M Deutschland GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like 3M Deutschland GmbH’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