FDA applicant
Tiger Medical Products, Ltd.
FDA records 6 decisions for Tiger Medical Products, Ltd. (Shanghai, CN) from 2005 to 2016: 6 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 14 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Tiger Medical Products”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tiger Medical Products, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Tiger Medical Products, 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 “Tiger”
FDA records each applicant name separately; these may or may not be the same firm.