Bionix Development Corp.
Medical device manufacturer in Toledo, OH.
13510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K180605 | GastroFlushKNT · Traditional | 10/24/2018SE |
| K153270 | TruGuard Custom Tongue and Jaw PositionerIYE · Traditional | 03/08/2016SE |
| K123411 | Little Angels Swaddling BlanketPDH · Traditional | 03/07/2013SE |
| K120335 | Embrace ThermoplasticIYE · Traditional | 05/03/2012SE |
| K100691 | Omni V SBRT Positioning System, Model RT-4500IYE · Traditional | 05/11/2010SE |
| K100264 | T-Form Extremity Immobilizer, Model RT-6060IYE · Traditional | 04/09/2010SE |
| K050701 | Thigh and Foot Positioner, Suprone Plus, Model RT-6010IYE · Traditional | 04/01/2005SE |
| K040773 | Pelvis Bellyboard Plus Patient Positioning SystemIYE · Traditional | 04/09/2004SE |
| K030051 | Versaboard, Model 7040IYE · Traditional | 04/04/2003SE |
| K933614 | Pituitary BoardIYE · Traditional | 10/07/1993SE |
| K933613 | 3-WAY Head Immobilizer; 3WAY Deluxe Reusable Frame Head ImmobilizerIYE · Traditional | 10/07/1993SE |
| K905007 | Standard Breast Boards; Deluxe Breast BoardIYE · Traditional | 02/12/1991SE |
| K900370 | One/Circ (Circumcision Clamp)HFX · Traditional | 04/16/1990SE |