FDA applicant
Fertilis Pty, Ltd.
FDA records 1 decision for Fertilis Pty, Ltd. (Adelaide, AU) in 2026: 1 510(k) clearance. All are in product code MQK (Labware, Assisted Reproduction). 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 Fertilis Pty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026high 1 (2026)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like Fertilis 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) Report