FDA applicant
Dragon Heart Medical Devices Co., Ltd.
FDA records 2 decisions for Dragon Heart Medical Devices Co., Ltd. (Elmhurst, IL) from 2004 to 2005: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FMF (Syringe, Piston). 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 Dragon Heart Medical Devices Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dragon Heart Medical Devices Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Dragon Heart Medical Devices 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 “Dragon”
FDA records each applicant name separately; these may or may not be the same firm.