FDA applicant
Venner Medical (Singapore) Pte, Ltd.
FDA records 6 decisions for Venner Medical (Singapore) Pte, Ltd. (Singapore, SG) from 2010 to 2020: 6 510(k) clearances. Most are in product codes BTO (Tube, Tracheostomy (W/Wo Connector)) and BTR (Tube, Tracheal (W/Wo Connector)). Its devices cite 4 predicates, 2 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 Venner Medical (Singapore) Pte, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Venner Medical (Singapore) Pte, 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