FDA applicant
Ttk Biomed, Ltd.
FDA records 1 decision for Ttk Biomed, Ltd. (Washington, DC) in 1996: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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 Ttk Biomed, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ttk Biomed, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ttk Biomed, 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