510(k) Report

FDA applicant

Parexel Intl. Corp.

Cambridge, MA14 decisions1984–19910 recalls

FDA records 14 decisions for Parexel Intl. Corp. (Cambridge, MA) from 1984 to 1991: 14 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and DSI (Detector And Alarm, Arrhythmia). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Parexel Intl. Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Parexel Intl. Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Parexel Intl. Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Parexel”

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