# Bioform, Inc.

- Location (FDA's records): Franksville, WI
- FDA decisions: 4 (2001–2003): 4 510(k) clearances
- Product codes: MIX (1), NEU (1), LYC (1), KHJ (1)
- Predicates its devices cite: 18 (2 its own); citations of its devices by later devices: 12 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coors Biomedical Co.: 2 (https://510kreport.com/company/coors-biomedical)
- Usbiomaterials Corp.: 2 (https://510kreport.com/company/usbiomaterials)
- Trinity Laboratories, Inc.: 1 (https://510kreport.com/company/trinity-laboratories)
- Advanced Uroscience, Inc.: 1 (https://510kreport.com/company/advanced-uroscience)
- Senorx, Inc.: 1 (https://510kreport.com/company/senorx)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Calcitek, Inc.: 1 (https://510kreport.com/company/calcitek)
- Orthomatrix, Inc.: 1 (https://510kreport.com/company/orthomatrix)

## Firms that cite its devices most
- Cytophil, Inc.: 3 (https://510kreport.com/company/cytophil)
- Bioform Medical, Inc.: 2 (https://510kreport.com/company/bioform-medical)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Augmenix, Inc.: 1 (https://510kreport.com/company/augmenix)
- Mathys Corp.: 1 (https://510kreport.com/company/mathys)
- Osteotech, Inc.: 1 (https://510kreport.com/company/osteotech)
- Coapt Systems, Inc.: 1 (https://510kreport.com/company/coapt-systems)

## Its most-cited devices
- K030682: Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3 (2003), cited by 4
- K013243: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 (2002), cited by 4
- K033398: Laryngeal Augmentation Implant (2003), cited by 2
- K012955: Coaptite Tissue Marker and Coaptite FN Tissue Marker (2001), cited by 2

## Recent decisions
- K033398: Laryngeal Augmentation Implant (Dec 12, 2003)
- K030682: Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3 (Jun 27, 2003)
- K013243: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 (Jan 9, 2002)
- K012955: Coaptite Tissue Marker and Coaptite FN Tissue Marker (Oct 22, 2001)

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