FDA applicant
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
FDA records 3 decisions for Aroa Biosurgery Limited (Formerly Mesynthes Limited) (Auckland, NZ) in 2016: 3 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and FTL (Mesh, Surgical, Polymeric). Since 2016 its 510(k)s took a median of 109 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. 21 recalls are linked to its devices.
FDA’s records also spell it “Aroa Biosurgery (Formerly Mesynthes Limited)”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aroa Biosurgery Limited (Formerly Mesynthes Limited)’s devices, and how often a recall has named them.
FDA decisions per year
3in 2016
2026 so far, outlined.
Recalls per year
21in 2018
Class I Class II/III not classified
Planning a device like Aroa Biosurgery Limited (Formerly…’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 “Aroa”
FDA records each applicant name separately; these may or may not be the same firm.