Bionix Development Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K153270 | TruGuard Custom Tongue and Jaw Positioner | March 8, 2016 |
| K123411 | LITTLE ANGELS SWADDLING BLANKET | March 7, 2013 |
| K120335 | EMBRACE THERMOPLASTIC | May 3, 2012 |
| K100691 | OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 | May 11, 2010 |
| K100264 | T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 | April 9, 2010 |
| K050701 | THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 | April 1, 2005 |
| K040773 | PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM | April 9, 2004 |
| K030051 | VERSABOARD, MODEL 7040 | April 4, 2003 |
| K933614 | PITUITARY BOARD | October 7, 1993 |
| K933613 | 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER | October 7, 1993 |
| K905007 | STANDARD BREAST BOARDS; DELUXE BREAST BOARD | February 12, 1991 |
| K900370 | ONE/CIRC (CIRCUMCISION CLAMP) | April 16, 1990 |