Hartalega NGC Sdn. Bhd. - FDA 510(k) Cleared Devices

Hartalega NGC Sdn. Bhd. has 28 FDA 510(k) cleared general hospital devices. Based in Bandar Sri Damansara, MY.

Latest FDA clearance: Oct 2025. Active since 2014.

Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Hartalega Sdn Bhd as regulatory consultant.