FDA applicant
Defender Safety, Inc.
FDA records 2 decisions for Defender Safety, Inc. (Plainview, NY) in 2021: 2 510(k) clearances. All are in product code FXX (Mask, Surgical). 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 Defender Safety, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2021
2021high 2 (2021) · low 0 (2022)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Defender Safety, Inc.’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