FDA applicant
New York Embroidery Studio
FDA records 1 decision for New York Embroidery Studio (Brooklyn, NY) in 2026: 1 510(k) clearance. All are in product code FYA (Gown, 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 New York Embroidery Studio’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026high 1 (2026)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like New York Embroidery Studio’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