FDA applicant
Apex Medical Corp.
FDA records 36 decisions for Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW) from 1987 to 2022: 36 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Since 2016 its 510(k)s took a median of 255 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 10 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Apex Medical, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Apex Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Apex Medical Corp.’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 “Apex”
FDA records each applicant name separately; these may or may not be the same firm.