# Concert Medical, LLC

- Location (FDA's records): Norwell, MA
- FDA decisions: 3 (2009–2016): 3 510(k) clearances
- Product codes: DQX (2), FRN (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 2 (0 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
- Lake Region Medical: 2 (https://510kreport.com/company/lake-region-medical)
- Biotronik, Inc.: 2 (https://510kreport.com/company/biotronik)
- Byron Medical: 1 (https://510kreport.com/company/byron-medical)

## Firms that cite its devices most
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Medovate Limited: 1 (https://510kreport.com/company/medovate)

## Its most-cited devices
- K153599: Concert Medical Hands-Free Syringe (HFS) (2016), cited by 1
- K153397: S-Wire Guidewire System (2016), cited by 1

## Recent decisions
- K153599: Concert Medical Hands-Free Syringe (HFS) (Sep 1, 2016)
- K153397: S-Wire Guidewire System (Aug 18, 2016)
- K090193: Conductor Coronary Guidewire (Sep 25, 2009)

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