FDA applicant
Samsung Sds Co., Ltd.
FDA records 6 decisions for Samsung Sds Co., Ltd. (Aubrey, TX) from 1999 to 2000: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LMD (System, Digital Image Communications…). Its devices cite 5 predicates, 0 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 Samsung Sds Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Samsung Sds Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Samsung Sds 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.