510(k) Report

FDA applicant

Crosstex International

Rush, NY6 decisions2008–20140 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Crosstex International’s devices, and how often a recall has named them.

FDA decisions per year

3in 2014

2008: 12010: 12011: 12014: 3
2008high 3 (2014) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Crosstex International by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Crosstex”

FDA records each applicant name separately; these may or may not be the same firm.