FDA applicant
New Medical Co., Ltd.
FDA records 6 decisions for New Medical Co., Ltd. (Taipei, TW) from 2007 to 2012: 6 510(k) clearances. All are in product code MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 4 predicates, 3 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 New Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like New Medical 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