Headstar Medical Products Co., Ltd.

FDA Regulatory Profile

Headstar Medical Products Co., Ltd. has 0 FDA recalls, 3 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 22, 2025 · VAI
Latest 510(k)
Apr 17, 2013

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 22, 2025New Taipei City, TaiwanDevicesVoluntary Action Indicated (VAI)3003418980
Dec 15, 2016New Taipei City, TaiwanDevicesVoluntary Action Indicated (VAI)3003418980
Nov 5, 2009New Taipei City, TaiwanDevicesVoluntary Action Indicated (VAI)3003418980

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3003418980New Taipei City, Taiwan3May 22, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K121770HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZERApr 17, 2013
K002846HEADSTAR'S MANUAL EMERGENCY RESUSCITATORJun 6, 2001

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.