FDA applicant
GE Healthcare
FDA records 172 decisions for GE Healthcare (Wauwatosa, WI) from 2000 to 2026: 169 510(k) clearances and 3 original PMA approvals. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 289 predicates, 133 of them its own earlier devices. 259 recalls are linked to its devices, 10 Class I.
FDA’s records also spell it “Ge Healthcare GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided GE Healthcare’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
12in 2026
Class I Class II/III not classified
Planning a device like GE Healthcare’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