Bioform, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Bioform, Inc. makes
Bioform, Inc. manufactures laryngeal augmentation implants and systems, including calcium hydroxylapatite-based devices for vocal cord augmentation. These include the Coaptite Laryngeal Augmentation System in 0.5cc and 1cc volumes, as well as standalone laryngeal augmentation implants. The portfolio also includes tissue markers for surgical guidance, such as the Coaptite Tissue Marker and Coaptite FN Tissue Marker.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Laryngeal Augmentation Implant Ref K033398
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioform, Inc. have in the registry?
The registry currently lists 4 devices for Bioform, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioform, Inc.'s devices?
Among its 4 most recently registered devices, Bioform, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Bioform, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Bioform, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioform, Inc. in the registry?
The most recently registered devices listed for Bioform, Inc. include COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1, CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3, LARYNGEAL AUGMENTATION IMPLANT and COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER.