FDA applicant
Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.
FDA records 1 decision for Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. (Yilan County, TW) in 2025: 1 510(k) clearance. All are in product code FRG (Wrap, Sterilization). Its devices cite 1 predicate, 0 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 Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Medicom Asia-Pacific Holdings 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) ReportOther applicant names beginning “Medicom”
FDA records each applicant name separately; these may or may not be the same firm.