Company ยท US
Bionix Development Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2018. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 24, 2018 | K180605 | GastroFlush Bionix Development Corporation | KNT |
| Mar 8, 2016 | K153270 | TruGuard Custom Tongue and Jaw Positioner Bionix Development Corp. | IYE |
| Mar 7, 2013 | K123411 | LITTLE ANGELS SWADDLING BLANKET Bionix Development Corp. | PDH |
| May 3, 2012 | K120335 | EMBRACE THERMOPLASTIC Bionix Development Corp. | IYE |
| May 11, 2010 | K100691 | OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 Bionix Development Corp. | IYE |
| Apr 9, 2010 | K100264 | T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 Bionix Development Corp. | IYE |
| Apr 1, 2005 | K050701 | THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 Bionix Development Corp. | IYE |
| Apr 9, 2004 | K040773 | PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM Bionix Development Corp. | IYE |
| Apr 4, 2003 | K030051 | VERSABOARD, MODEL 7040 Bionix Development Corp. | IYE |
| Oct 7, 1993 | K933614 | PITUITARY BOARD Bionix Development Corp. | IYE |
| Oct 7, 1993 | K933613 | 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER Bionix Development Corp. | IYE |
| Feb 12, 1991 | K905007 | STANDARD BREAST BOARDS; DELUXE BREAST BOARD Bionix Development Corp. | IYE |
| Apr 16, 1990 | K900370 | ONE/CIRC (CIRCUMCISION CLAMP) Bionix Development Corp. | HFX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||