Medical Device Manufacturer · US , San Clemente , CA

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

10 submissions · 10 cleared · Since 2013

10

Total

10

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared Nov 07, 2017

Compressyn™ Staple

Orthopedic · 172d

Cleared May 07, 2015

Orthopedic · 84d

Cleared Feb 11, 2015

Orthopedic · 106d

Cleared Aug 21, 2014

TENSYN BAND, TENSYN FRACTURE PLATES

Orthopedic · 98d

Cleared Jun 02, 2014

COMPRESSYN STAPLE

Orthopedic · 110d

Cleared Feb 28, 2014

Orthopedic · 71d

Cleared Dec 30, 2013

COMPRESSYN STAPLE

Orthopedic · 108d

Cleared Nov 15, 2013

Orthopedic · 147d

Cleared Jul 25, 2013

COMPRESSYN BAND

Orthopedic · 154d

Cleared Feb 07, 2013

COMPRESSYN STAPLE

Orthopedic · 141d

Data Source

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

Last updated: Apr 27, 2026