FDA applicant
Ge Medical Systems China Co., Ltd.
FDA records 13 decisions for Ge Medical Systems China Co., Ltd. (Wuxi, Jiangsu Province, CN) from 2009 to 2017: 13 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 21 predicates, 8 of them its own earlier devices. 6 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Ge Medical Systems (China) Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ge Medical Systems China Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Ge Medical Systems China 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