FDA applicant
Swank Plus, Ltd.
FDA records 3 decisions for Swank Plus, Ltd. (Hong Kong, HK) in 1988: 3 510(k) clearances. Most are in product codes HOT (Aid, Vision Image Intensification) and HQY (Sunglasses (Non-Prescription Including…). 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 Swank Plus, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Swank Plus, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Swank Plus, 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