# Dallen Medical, Inc.

- Location (FDA's records): San Clemente, CA
- FDA decisions: 11 (2011–2017): 11 510(k) clearances
- Names in FDA's records: Dallen Medical, Inc. (10); Dallen Medical (1)
- Product codes: HTN (5), JDR (4), JDQ (2)
- Predicates its devices cite: 31 (11 its own); citations of its devices by later devices: 13 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 5 (https://510kreport.com/company/arthrex)
- Biomet Sports Medicine: 3 (https://510kreport.com/company/biomet-sports-medicine)
- Biomedical Ent., Inc.: 2 (https://510kreport.com/company/biomedical-ent)
- ETHICON, Inc.: 2 (https://510kreport.com/company/ethicon)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- 3M Company: 1 (https://510kreport.com/company/3m)
- New Deal, S.A.: 1 (https://510kreport.com/company/new-deal)
- Orthohelix Surgical Designs, Inc.: 1 (https://510kreport.com/company/orthohelix-surgical-designs)

## Firms that cite its devices most
- Exotoe, LLC: 1 (https://510kreport.com/company/exotoe)
- Coracoid Solutions, Inc.: 1 (https://510kreport.com/company/coracoid-solutions)

## Its most-cited devices
- K131850: Tensyn Band (2013), cited by 3
- K122871: Compressyn Staple (2013), cited by 2
- K140358: Compressyn Staple (2014), cited by 2
- K130431: Compressyn Band (2013), cited by 1
- K143092: Tensyn Plug (2015), cited by 1
- K133858: Tensyn Band (2014), cited by 1

## Recent decisions
- K171473: Compressyn™ Staple (Nov 7, 2017)
- K150359: Tensyn Plug (May 7, 2015)
- K143092: Tensyn Plug (Feb 11, 2015)
- K141264: Tensyn Band, Tensyn Fracture Plates (Aug 21, 2014)
- K140358: Compressyn Staple (Jun 2, 2014)
- K133858: Tensyn Band (Feb 28, 2014)
- K132875: Compressyn Staple (Dec 30, 2013)
- K131850: Tensyn Band (Nov 15, 2013)

Source page: https://510kreport.com/company/dallen-medical