FDA applicant
Merits Medical Industries Co., Ltd.
FDA records 1 decision for Merits Medical Industries Co., Ltd. (Cape Coral, FL) in 2001: 1 510(k) clearance. All are in product code INI (Vehicle, Motorized 3-Wheeled). 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Merits Medical Industries Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Merits Medical Industries Co., Ltd. since 2007.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Merits Medical Industries 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 “Merits”
FDA records each applicant name separately; these may or may not be the same firm.