FDA applicant
William A. Cook Australia Pty., Ltd.
FDA records 14 decisions for William A. Cook Australia Pty., Ltd. (Eight Mile Plains, AU) from 2009 to 2018: 14 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQE (Needle, Assisted Reproduction). Since 2016 its 510(k)s took a median of 197 days from receipt to decision, against 170 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided William A. Cook Australia Pty., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like William A. Cook Australia Pty., 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) ReportOther applicant names beginning “William”
FDA records each applicant name separately; these may or may not be the same firm.