FDA applicant
Ximed/Prosure/Injectx
FDA records 9 decisions for Ximed/Prosure/Injectx (San Jose, CA) from 1995 to 2001: 9 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GAA (Needle, Aspiration And Injection, Disposable). 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 Ximed/Prosure/Injectx’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ximed/Prosure/Injectx since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ximed/Prosure/Injectx’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 “Ximed/Prosure/Injectx”
FDA records each applicant name separately; these may or may not be the same firm.