FDA applicant
Dmc Medical, Ltd.
FDA records 3 decisions for Dmc Medical, Ltd. (Fullerton, CA) from 2000 to 2011: 3 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and GBX (Catheter, Irrigation). Its devices cite 2 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 Dmc Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Dmc Medical, 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