Bionix Development Corp.
United StatesFDA applicant, unverified
- Devices
- 13
What Bionix Development Corp. makes
Bionix Development Corp. manufactures medical positioning and immobilization devices, including swaddling blankets, thermoplastic molds like the Embrace and T-Form Extremity Immobilizer, reusable head immobilizers, and specialized boards for breast, pelvis, and extremity support. Their portfolio also covers radiation therapy accessories such as the Omni V SBRT positioning system and custom tongue/jaw positioners, as well as a circumcision clamp. Additional products include reusable frames, foot/thigh positioners, and reusable breast boards.
All listed devices fall under FDA Class II regulation and are cleared via the 510(k) pathway. The company’s products are registered with the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does Bionix Development Corp. have in the registry?
The registry currently lists 13 devices for Bionix Development Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bionix Development Corp.'s devices?
Among its 13 most recently registered devices, Bionix Development Corp. has devices listed in FDA 510(k) (13 devices).
What risk classes do Bionix Development Corp.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Bionix Development Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bionix Development Corp. in the registry?
The most recently registered devices listed for Bionix Development Corp. include LITTLE ANGELS SWADDLING BLANKET, GastroFlush, PITUITARY BOARD and 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER.