# Hemedex Incorporated

- Location (FDA's records): Hopkonton, MA
- FDA decisions: 4 (2002–2014): 4 510(k) clearances
- Product codes: GWM (2), DPW (1), KNY (1)
- Predicates its devices cite: 11 (1 its own); citations of its devices by later devices: 1 (1 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
- Vasamedics, LLC: 3 (https://510kreport.com/company/vasamedics)
- Integra Neurosciences: 2 (https://510kreport.com/company/integra-neurosciences)
- Transonic Systems, Inc.: 1 (https://510kreport.com/company/transonic-systems)
- Tsi, Inc.: 1 (https://510kreport.com/company/tsi)
- Uresil Corp.: 1 (https://510kreport.com/company/uresil)
- Codman & Shurtleff, Inc.: 1 (https://510kreport.com/company/codman-shurtleff)
- Johnson & Johnson Professionals, Inc.: 1 (https://510kreport.com/company/johnson-johnson-professionals)

## Its most-cited devices
- K032337: Hemedex Cranial Bolt Models, 3601, 3602 (2003), cited by 1

## Recent decisions
- K141869: Qflow 500 Titanium Bolt, Quad Lumen Bolt Kit (Oct 10, 2014)
- K032127: Hemedex Fixation Device (Dec 30, 2003)
- K032337: Hemedex Cranial Bolt Models, 3601, 3602 (Oct 21, 2003)
- K013376: Qflow 500 Perfusion Monitoring System (May 8, 2002)

Source page: https://510kreport.com/company/hemedex