Medical Device Manufacturer · NZ , Middleton

Enztec Limited - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2021

Total

Cleared

Denied

Enztec Limited has 5 FDA 510(k) cleared medical devices. Based in Middleton, NZ.

Last cleared in 2023. Active since 2021. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Enztec Limited Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Empirical Testing Corp and Empirical Technologies.

Enztec Limited is one of 14 FDA 510(k) medical device manufacturers from New Zealand in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Enztec Limited

5 devices

1-5 of 5

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 15, 2026