FDA applicant
Zefon Intl.
FDA records 2 decisions for Zefon Intl. (Ocala, FL) in 2008: 2 510(k) clearances. All are in product code DXQ (Blood Pressure Cuff). 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 Zefon Intl.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2008
2008high 2 (2008) · low 0 (2009)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Zefon Intl.’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) ReportOther applicant names beginning “Zefon”
FDA records each applicant name separately; these may or may not be the same firm.