Manufacturer Intelligence · Based on 57,940 FDA 510(k) records · 74 countries

FDA 510(k) Medical Device Manufacturers - New Zealand

Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

New Zealand medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

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Manufacturers

New Zealand

Country

New Zealand FDA 510(k) Overview

Manufacturers

Submissions

100%

Clearance rate

Leading New Zealand FDA 510(k) manufacturers include Fisher &Paykel Healthcare , Ltd., Adherium (Nz), Ltd., Aroa Biosurgery , Ltd. and 11 others.

New Zealand medical device manufacturers have submitted 66 FDA 510(k) notifications since 2018, achieving a 100% clearance rate across 14 manufacturers. New Zealand's medtech sector is characterized by specialized innovation in respiratory care, gastroenterology technology, advanced medical imaging and digital health solutions, with a high clearance efficiency reflecting strong submission quality.

Active in FDA 510(k) submissions since 2018. Many New Zealand manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) New Zealand Manufacturers

1–14 of 14

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Fisher &Paykel Healthcare , Ltd. Auckland, New Zealand	23	100%	AN	NZ
2	Adherium (Nz), Ltd. Auckland	9	100%	AN	NZ
3	Aroa Biosurgery , Ltd. Airport Oaks	7	100%	DE SU	NZ
4	Enztec Limited Middleton	5	100%	OR	NZ
5	Alimetry , Ltd. Grafton	5	100%	GU	NZ
6	Fisher & Paykel Healthcare Limited Auckland	4	100%	AN	NZ
7	Fisher & Paykel Healthcare Auckland	4	100%	AN	NZ
8	Fisher and Paykel Healthcare Limited Auckland	2	100%	AN	NZ
9	Volpara Health Technologies Limited Wellington	2	100%	RA	NZ
10	Mars Bioimaging , Ltd. Christchurch	1	100%	RA	NZ
11	Besorah Dental Solutions NZ Limited Auckland	1	100%	DE	NZ
12	Formus Labs, Ltd. Auckland	1	100%	RA	NZ
13	Medella Health Limited Tauranga	1	100%	PM	NZ
14	Innovative Health Technologies (Nz), Ltd. Dunedin	1	100%	DE	NZ

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.