FDA applicant
MEDA Co., Ltd.
FDA records 8 decisions for MEDA Co., Ltd. (Tianjin, CN) from 2007 to 2026: 8 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 237 days from receipt to decision, against 64 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Meda , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided MEDA Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like MEDA 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) ReportOther applicant names beginning “MEDA”
FDA records each applicant name separately; these may or may not be the same firm.