FDA applicant
Ge Medical System Israel, Ltd.
FDA records 4 decisions for Ge Medical System Israel, Ltd. (Wauwatosa, WI) from 2010 to 2012: 4 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 7 predicates, 2 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ge Medical System Israel, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2012
2026 so far, outlined.
Recalls per year
4in 2022
Class I Class II/III not classified
Planning a device like Ge Medical System Israel, 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