FDA applicant
Owandar Medical, Ltd.
FDA records 1 decision for Owandar Medical, Ltd. (Hp14 3xp, GB) in 1999: 1 510(k) clearance. All are in product code JEC (Component, Traction, Invasive). 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 Owandar Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Owandar Medical, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Owandar Medical, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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