# Biomerix Corporation

- Location (FDA's records): Fremont, CA
- FDA decisions: 6 (2005–2011): 6 510(k) clearances
- Product codes: FTL (5), KRD (1)
- Predicates its devices cite: 24 (5 its own); citations of its devices by later devices: 9 (5 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
- Tissue Science Laboratories, Plc: 3 (https://510kreport.com/company/tissue-science-laboratories)
- ETHICON, Inc.: 2 (https://510kreport.com/company/ethicon)
- Atrium Medical Corp.: 2 (https://510kreport.com/company/atrium-medical)
- Lifecell Corp.: 2 (https://510kreport.com/company/lifecell)
- Davol Inc., Sub. C. R. Bard, Inc.: 1 (https://510kreport.com/company/davol-sub-c-r-bard)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- American Medical Systems, Inc.: 1 (https://510kreport.com/company/american-medical-systems)
- Aga Medical Corp.: 1 (https://510kreport.com/company/aga-medical)

## Firms that cite its devices most
- Surgicraft, Ltd.: 1 (https://510kreport.com/company/surgicraft)
- Shape Memory Medical: 1 (https://510kreport.com/company/shape-memory-medical)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Xiros, Ltd.: 1 (https://510kreport.com/company/xiros)

## Its most-cited devices
- K070961: Biomerix Surgical Mesh, Model: RCR-01 (2008), cited by 4
- K082941: Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215 (2009), cited by 2
- K043371: Biomerix Vascular Occlusion Device and Loader (2005), cited by 2
- K093123: Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab (2010), cited by 1

## Recent decisions
- K112567: Biomerix Assure (Dec 23, 2011)
- K112499: Biomerix Composite Surgical Mesh (Dec 23, 2011)
- K093123: Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab (May 13, 2010)
- K082941: Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215 (Jan 7, 2009)
- K070961: Biomerix Surgical Mesh, Model: RCR-01 (Feb 25, 2008)
- K043371: Biomerix Vascular Occlusion Device and Loader (Feb 3, 2005)

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