FDA applicant
Headstar Medical Products Co., Ltd.
FDA records 2 decisions for Headstar Medical Products Co., Ltd. (City, Taipei County, TW) from 2001 to 2013: 2 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BTM (Ventilator, Emergency, Manual (Resuscitator)). 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 Headstar Medical Products Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Headstar Medical Products Co., 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