FDA applicant
Nemera
FDA records 1 decision for Nemera (Buffalo Grove, IL) in 2015: 1 510(k) clearance. All are in product code MEG (Syringe, Antistick). Its devices cite 1 predicate, 0 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 Nemera’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2015high 1 (2015) · low 0 (2016)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Nemera’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