Medical Device Manufacturer · US , San Clemente , CA

Dallen Medical, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2013

Total

Cleared

Denied

Dallen Medical, Inc. has 10 FDA 510(k) cleared orthopedic devices. Based in San Clemente, US.

Historical record: 10 cleared submissions from 2013 to 2017.

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

FDA 510(k) Regulatory Record - Dallen Medical, Inc.

10 devices

1-10 of 10

TENSYN BAND, TENSYN FRACTURE PLATES

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026

Dallen Medical, Inc. - FDA 510(k) Cleared Devices

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