FDA applicant
Samsung Medison Co., Ltd.
FDA records 75 decisions for Samsung Medison Co., Ltd. (Hongcheon-Gun, KR) from 2011 to 2026: 75 510(k) clearances. 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 89 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 190 predicates, 140 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Samsung Medison Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
2in 2019
Class I Class II/III not classified
Planning a device like Samsung Medison 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 “Samsung”
FDA records each applicant name separately; these may or may not be the same firm.