FDA applicant
Crosstex International
FDA records 6 decisions for Crosstex International (Rush, NY) from 2008 to 2014: 6 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and JOJ (Indicator, Physical/Chemical Sterilization…). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Crosstex International, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Crosstex International’s devices, and how often a recall has named them.
FDA decisions per year
3in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Crosstex International’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 “Crosstex”
FDA records each applicant name separately; these may or may not be the same firm.