FDA applicant
Manuka Health New Zealand, Ltd.
FDA records 1 decision for Manuka Health New Zealand, Ltd. (Bridgewater, NJ) in 2015: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). 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 Manuka Health New Zealand, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Manuka Health New Zealand, 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 “Manuka”
FDA records each applicant name separately; these may or may not be the same firm.