Bionix Development Corp. is one of 14071 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bionix Development Corp. - FDA 510(k) Cleared Devices
Recent clearances: TruGuard Custom Tongue and Jaw Positioner, LITTLE ANGELS SWADDLING BLANKET, EMBRACE THERMOPLASTIC
12
Total
12
Cleared
0
Denied
Bionix Development Corp. has 12 FDA 510(k) cleared radiology devices. Based in Toledo, US.
Historical record: 12 cleared submissions from 1990 to 2016.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Entela, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Bionix Development Corp.
12 devices
Cleared
Mar 08, 2016
TruGuard Custom Tongue and Jaw Positioner
Radiology
117d
Cleared
Mar 07, 2013
LITTLE ANGELS SWADDLING BLANKET
General Hospital
122d
Cleared
May 03, 2012
EMBRACE THERMOPLASTIC
Radiology
90d
Cleared
May 11, 2010
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500
Radiology
62d
Cleared
Apr 09, 2010
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060
Radiology
71d
Cleared
Apr 01, 2005
THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010
Radiology
14d
Cleared
Apr 09, 2004
PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM
Radiology
14d
Cleared
Apr 04, 2003
VERSABOARD, MODEL 7040
Radiology
88d
Cleared
Oct 07, 1993
3-WAY HEAD IMMOBILIZER
Radiology
80d
Cleared
Oct 07, 1993
PITUITARY BOARD
Radiology
80d
Cleared
Feb 12, 1991
STANDARD BREAST BOARDS
Radiology
98d
Cleared
Apr 16, 1990
ONE/CIRC (CIRCUMCISION CLAMP)
Obstetrics & Gynecology
81d