FDA applicant
Bioview, Ltd.
FDA records 5 decisions for Bioview, Ltd. (Kfar Saba, IL) from 2003 to 2014: 5 510(k) clearances. Most are in product codes JOY (Device, Automated Cell-Locating) and NTH (System, Automated Scanning Microscope And…). Its devices cite 19 predicates, 10 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 Bioview, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bioview, 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