Manufacturer Intelligence · Based on 21,267 FDA 510(k) records · 72 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.

Compare manufacturers by FDA 510(k) submission activity
Identify clearance rates, active panels and years of FDA activity
Filter by country or FDA review panel specialty

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., Aroa Biosurgery , Ltd., Enztec Limited and 10 others.

New Zealand medical device manufacturers have submitted 53 FDA 510(k) notifications since 2019, achieving a 100% clearance rate across 13 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 2019. Many New Zealand manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) New Zealand Manufacturers

1–13 of 13

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Fisher &Paykel Healthcare , Ltd. Auckland, New Zealand	22	100%	AN	NZ
2	Aroa Biosurgery , Ltd. Airport Oaks	5	100%	DE SU	NZ
3	Enztec Limited Middleton	5	100%	OR	NZ
4	Alimetry , Ltd. Grafton	5	100%	GU	NZ
5	Adherium (Nz), Ltd. Auckland	4	100%	AN	NZ
6	Fisher & Paykel Healthcare Limited Auckland	3	100%	AN	NZ
7	Fisher & Paykel Healthcare Auckland	3	100%	AN	NZ
8	Mars Bioimaging , Ltd. Christchurch	1	100%	RA	NZ
9	Fisher and Paykel Healthcare Limited Auckland	1	100%	AN	NZ
10	Volpara Health Technologies Limited Wellington	1	100%	RA	NZ
11	Formus Labs, Ltd. Auckland	1	100%	RA	NZ
12	Medella Health Limited Tauranga	1	100%	PM	NZ
13	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.