FDA applicant
Sialo Technology, Ltd.
FDA records 4 decisions for Sialo Technology, Ltd. (Kfar Saba, IL) from 2008 to 2010: 4 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and OAJ (Catheter, Drainage, Intraoral/Extraoral). Its devices cite 9 predicates, 0 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 Sialo Technology, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Sialo Technology, 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