FDA applicant
Wisebands, Ltd.
FDA records 1 decision for Wisebands, Ltd. (Ra'Anana, IL) in 2001: 1 510(k) clearance. All are in product code MKY (System, Skin Closure). 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 Wisebands, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Wisebands, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Wisebands, 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